• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Philips see related information
Date Initiated by Firm August 11, 2021
Create Date September 03, 2021
Recall Status1 Open3, Classified
Recall Number Z-2411-2021
Recall Event ID 88491
510(K)Number K110151  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities
Models:
781341
781396
Code Information Model: 781341 Serial Number Unique Device Identifier (UDI#) 70085 N/A 70160 N/A 70246 N/A 70349 N/A 70348 N/A 70407 N/A 70723 N/A 70873 N/A 70917 N/A 87101 (01)00884838055322(21)87101 70040 N/A 70229 N/A 70607 N/A 70763 N/A 84126 (01)00884838055322(21)84126 84030 (01)00884838055322(21)84030 84108 (01)00884838055322(21)84108 84234 (01)00884838055322(21)84234 84257 N/A 84596 (01)00884838055322(21)84596 87005 (01)00884838055322(21)87005 87146 (01)00884838055322(21)87146 70279 N/A 70367 N/A 70374 N/A 70375 N/A 70461 N/A 70471 N/A 70742 N/A 70764 N/A 70064 N/A 70113 N/A 70604 N/A 70603 N/A 70605 N/A 70725 N/A 70704 N/A 70768 N/A 70794 N/A 70766 N/A 70812 N/A 70767 N/A 84539 (01)00884838055322(21)84539 70780 N/A 84566 (01)00884838055322(21)84566 84621 (01)00884838055322(21)84621 84667 (01)00884838055322(21)84667 84629 (01)00884838055322(21)84629 84962 (01)00884838055322(21)84962 87214 (01)00884838055322(21)87214 87215 (01)00884838055322(21)87215 70071 N/A 70284 N/A 70311 N/A 70916 N/A 84098 (01)00884838055322(21)84098 84343 (01)00884838055322(21)84343 84249 (01)00884838055322(21)84249 84891 (01)00884838055322(21)84891 84765 (01)00884838055322(21)84765 70110 N/A 70111 N/A 70177 N/A 70161 N/A 70204 N/A 70205 N/A 70244 N/A 70269 N/A 70088 N/A 70446 N/A 70448 N/A 70470 N/A 70665 N/A 70678 N/A 70459 N/A 70755 N/A 70666 N/A 70664 N/A 70663 N/A 70667 N/A 70668 N/A 70662 N/A 70864 N/A 70845 N/A 70943 N/A 70942 N/A 70866 N/A 70868 N/A 70867 N/A 70969 N/A 70691 N/A 70612 (01)00884838055322(21)70612 84178 (01)00884838055322(21)84178 84179 (01)00884838055322(21)84179 84180 (01)00884838055322(21)84180 84300 (01)00884838055322(21)84300 84302 (01)00884838055322(21)84302 84381 (01)00884838055322(21)84381 84330 (01)00884838055322(21)84330 84303 (01)00884838055322(21)84303 84385 (01)00884838055322(21)84622 84384 (01)00884838055322(21)84384 84387 (01)00884838055322(21)84387 84451 (01)00884838055322(21)84451 84976 (01)00884838055322(21)84976 87028 (01)00884838055322(21)87028 84844 (01)00884838055322(21)84844 87271 (01)00884838055322(21)87271 84622 (01)00884838055322(21)84385 87040 (01)00884838055322(21)87040 87061 (01)00884838055322(21)87061 87098 (01)00884838055322(21)87098 87124 (01)00884838055322(21)87124 87125 (01)00884838055322(21)87125 87126 (01)00884838055322(21)87126 87180 (01)00884838055322(21)87180 87206 (01)00884838055322(21)87206 87207 (01)00884838055322(21)87207 87221 (01)00884838055322(21)87221 87222 (01)00884838055322(21)87222 70488 N/A 70832 N/A 70286 N/A 70221 N/A 70655 N/A 70641 N/A 70730 N/A 70712 N/A 70858 N/A 70851 N/A 84644 (01)00884838055322(21)84644 84649 (01)00884838055322(21)84649 70067 N/A 70074 N/A 70101 N/A 70114 N/A 70104 N/A 70073 N/A 70009 N/A 70278 N/A 70206 N/A 70306 N/A 70452 N/A 70623 N/A 70622 N/A 70590 N/A 70589 N/A 70588 N/A 70696 N/A 70705 N/A 70754 N/A 84042 N/A 70869 N/A 70975 (01)00884838055322(21)70975 84084 (01)00884838055322(21)84084 84203 (01)00884838055322(21)84203 84315 (01)00884838055322(21)84315 84555 (01)00884838055322(21)84555 84268 (01)00884838055322(21)84268 84788 N/A 87027 (01)00884838055322(21)87027 70424 N/A 84092 (01)00884838055322(21)84092 84311 (01)00884838055322(21)84311 84766 (01)00884838055322(21)84766 84744 (01)00884838055322(21)84744 84890 (01)00884838055322(21)84890 84730 (01)00884838055322(21)84730 84986 (01)00884838055322(21)84986 84982 (01)00884838055322(21)84982 87151 (01)00884838055322(21)87151 87171 (01)00884838055322(21)87171 87191 (01)00884838055322(21)87191 84010 N/A 70981 N/A 84082 N/A 84110 (01)00884838055322(21)84110 70997 (01)00884838055322(21)70997 84066 (01)00884838055322(21)84066 84197 (01)00884838055322(21)84197 70974 (01)00884838055322(21)70974 84150 (01)00884838055322(21)84150 84204 (01)00884838055322(21)84204 84242 (01)00884838055322(21)84242 70987 (01)00884838055322(21)70987 84230 (01)00884838055322(21)84230 84262 (01)00884838055322(21)84262 84291 (01)00884838055322(21)84291 84256 N/A 84290 (01)00884838055322(21)84290 84310 (01)00884838055322(21)84310 84287 (01)00884838055322(21)84287 84321 (01)00884838055322(21)84321 84318 (01)00884838055322(21)84318 84320 (01)00884838055322(21)84320 84383 (01)00884838055322(21)84383 84327 (01)00884838055322(21)84327 84397 (01)00884838055322(21)84397 84503 (01)00884838055322(21)84503 84411 (01)00884838055322(21)84411 84452 (01)00884838055322(21)84452 84328 (01)00884838055322(21)84328 84417 (01)00884838055322(21)84417 84307 (01)00884838055322(21)84307 84414 (01)00884838055322(21)84414 84515 (01)00884838055322(21)84515 84496 (01)00884838055322(21)84496 84582 (01)00884838055322(21)84582 84497 (01)00884838055322(21)84497 84585 (01)00884838055322(21)84585 84695 (01)00884838055322(21)84695 84427 (01)00884838055322(21)84427 84422 (01)00884838055322(21)84422 84591 (01)00884838055322(21)84591 84399 (01)00884838055322(21)84399 84756 (01)00884838055322(21)84756 84597 N/A 84645 (01)00884838055322(21)84645 84787 (01)00884838055322(21)84787 84686 (01)00884838055322(21)84686 84736 (01)00884838055322(21)84736 84531 (01)00884838055322(21)84531 84640 (01)00884838055322(21)84640 84755 (01)00884838055322(21)84755 84723 (01)00884838055322(21)84723 84655 (01)00884838055322(21)84655 84770 (01)00884838055322(21)84770 84673 (01)00884838055322(21)84673 84389 N/A 84668 (01)00884838055322(21)84668 84525 (01)00884838055322(21)84525 84812 (01)00884838055322(21)84812 84795 (01)00884838055322(21)84795 84813 (01)00884838055322(21)84813 84588 (01)00884838055322(21)84588 84842 (01)00884838055322(21)84842 84810 (01)00884838055322(21)84810 84822 (01)00884838055322(21)84822 84833 (01)00884838055322(21)84833 84532 (01)00884838055322(21)84532 84857 (01)00884838055322(21)84857 84861 (01)00884838055322(21)84861 84608 (01)00884838055322(21)84608 84837 (01)00884838055322(21)84837 84863 (01)00884838055322(21)84863 84845 (01)00884838055322(21)84845 84881 (01)00884838055322(21)84881 84872 (01)00884838055322(21)84872 84831 (01)00884838055322(21)84831 84882 (01)00884838055322(21)84882 84922 (01)00884838055322(21)84922 84909 (01)00884838055322(21)84909 84928 (01)00884838055322(21)84928 84947 (01)00884838055322(21)84947 84917 (01)00884838055322(21)84917 84855 (01)00884838055322(21)84855 84965 (01)00884838055322(21)84965 84905 (01)00884838055322(21)84905 87009 (01)00884838055322(21)87009 84984 (01)00884838055322(21)84984 84990 (01)00884838055322(21)84990 84859 (01)00884838055322(21)84859 87029 (01)00884838055322(21)87029 84830 (01)00884838055322(21)84830 87054 (01)00884838055322(21)87054 87048 (01)00884838055322(21)87048 87045 (01)00884838055322(21)87045 87109 (01)00884838055322(21)87109 87123 (01)00884838055322(21)87123 87084 (01)00884838055322(21)87084 87110 (01)00884838055322(21)87110 87062 (01)00884838055322(21)87062 87065 (01)00884838055322(21)87065 87174 (01)00884838055322(21)87174 84997 (01)00884838055322(21)84997 84692 (01)00884838055322(21)84692 84946 (01)00884838055322(21)84946 87192 (01)00884838055322(21)87192 87202 (01)00884838055322(21)87202 87201 (01)00884838055322(21)87201 84943 (01)00884838055322(21)84943 87233 (01)00884838055322(21)87233 87056 (01)00884838055322(21)87056 87142 (01)00884838055322(21)87142 87224 (01)00884838055322(21)87224 87240 (01)00884838055322(21)87240 87227 (01)00884838055322(21)87227 87241 (01)00884838055322(21)87241 87254 (01)00884838055322(21)87254 84153 N/A 84542 N/A 84551 (01)00884838055322(21)84551 87112 (01)00884838055322(21)87112 70333 N/A 70369 N/A 70778 N/A 70803 N/A 70980 N/A 70965 N/A 84195 (01)00884838055322(21)84195 84408 (01)00884838055322(21)84408 84407 (01)00884838055322(21)84407 84547 (01)00884838055322(21)84547 84669 (01)00884838055322(21)84669 84687 (01)00884838055322(21)84687 87058 (01)00884838055322(21)87058 70029 N/A 70021 N/A 70046 N/A 70099 N/A 70129 N/A 70199 N/A 70202 N/A 70233 N/A 70289 N/A 70223 N/A 70294 N/A 70302 N/A 70232 N/A 70277 N/A 70313 N/A 70376 N/A 70381 N/A 70427 N/A 70463 N/A 70583 N/A 70626 N/A 70680 N/A 70692 N/A 70679 N/A 70464 N/A 70611 N/A 70596 N/A 70785 N/A 70784 N/A 70684 N/A 70660 N/A 70854 N/A 70870 N/A 70948 N/A 70799 N/A 70921 N/A 70881 N/A 70855 N/A 70986 (01)00884838055322(21)70986 70993 (01)00884838055322(21)70993 70992 (01)00884838055322(21)70992 70886 (01)00884838055322(21)70886 84187 (01)00884838055322(21)84187 84104 (01)00884838055322(21)84104 84131 (01)00884838055322(21)84131 84122 (01)00884838055322(21)84122 84207 (01)00884838055322(21)84207 84016 (01)00884838055322(21)84016 84228 (01)00884838055322(21)84228 84116 (01)00884838055322(21)84116 84259 (01)00884838055322(21)84259 84388 (01)00884838055322(21)84388 84423 N/A 84453 (01)00884838055322(21)84453 84454 (01)00884838055322(21)84454 84557 (01)00884838055322(21)84557 84544 (01)00884838055322(21)84544 84624 (01)00884838055322(21)84624 84564 N/A 84565 (01)00884838055322(21)84565 84574 (01)00884838055322(21)84574 84725 (01)00884838055322(21)84725 84632 (01)00884838055322(21)84632 84718 (01)00884838055322(21)84718 84652 (01)00884838055322(21)84652 84829 (01)00884838055322(21)84829 84914 (01)00884838055322(21)84914 84939 (01)00884838055322(21)84939 84996 (01)00884838055322(21)84996 87252 (01)00884838055322(21)87252 87249 (01)00884838055322(21)87249 84107 (01)00884838055322(21)84107 84654 (01)00884838055322(21)84654 70032 N/A 70249 N/A 70250 N/A 70258 N/A 84093 (01)00884838055322(21)84093 84136 (01)00884838055322(21)84136 84141 (01)00884838055322(21)84141 84202 (01)00884838055322(21)84202 84488 (01)00884838055322(21)84488 87141 (01)00884838055322(21)87141 84664 (01)00884838055322(21)84664 70601 N/A 87008 (01)00884838055322(21)87008 84704 (01)00884838055322(21)84704 84705 (01)00884838055322(21)84705 70296 N/A 70597 N/A 70818 N/A 70885 N/A 70976 N/A 84051 N/A 84166 (01)00884838055322(21)84166 84175 (01)00884838055322(21)84175 84176 (01)00884838055322(21)84176 84164 (01)00884838055322(21)84164 70991 (01)00884838055322(21)70991 84167 (01)00884838055322(21)84167 84165 (01)00884838055322(21)84165 84323 (01)00884838055322(21)84323 84322 (01)00884838055322(21)84322 84342 (01)00884838055322(21)84342 84425 (01)00884838055322(21)84425 84471 (01)00884838055322(21)84471 84593 (01)00884838055322(21)84593 84742 (01)00884838055322(21)84742 87139 (01)00884838055322(21)87139 87247 (01)00884838055322(21)87247 70123 N/A 70226 N/A 70251 N/A 70295 N/A 70364 N/A 70344 N/A 70435 N/A 70656 N/A 70629 N/A 70846 N/A 70787 N/A 70890 N/A 84004 N/A 84205 (01)00884838055322(21)84205 84312 (01)00884838055322(21)84312 84332 (01)00884838055322(21)84332 84442 (01)00884838055322(21)84442 84476 (01)00884838055322(21)84476 84313 (01)00884838055322(21)84313 84568 (01)00884838055322(21)84568 84576 (01)00884838055322(21)84576 84584 (01)00884838055322(21)84584 84378 (01)00884838055322(21)84378 84592 (01)00884838055322(21)84592 84663 (01)00884838055322(21)84663 84773 (01)00884838055322(21)84773 84774 (01)00884838055322(21)84774 84371 (01)00884838055322(21)84371 84740 (01)00884838055322(21)84740 84549 (01)00884838055322(21)84549 84896 (01)00884838055322(21)84896 87039 (01)00884838055322(21)87039 87119 (01)00884838055322(21)87119 87004 (01)00884838055322(21)87004 87134 (01)00884838055322(21)87134 87034 (01)00884838055322(21)87034 70235 N/A 70383 N/A 70796 N/A 84412 (01)00884838055322(21)84412 70043 N/A 70068 N/A 70270 N/A 70239 N/A 70228 N/A 70312 N/A 70321 N/A 70276 N/A 70598 N/A 70651 N/A 70683 N/A 70708 N/A 70673 N/A 70617 N/A 70593 N/A 70738 N/A 70709 N/A 70630 N/A 70737 N/A 70865 N/A 70860 N/A 70889 N/A 70929 N/A 70844 N/A 70927 N/A 70938 N/A 70973 N/A 70908 N/A 70966 N/A 84011 (01)00884838055322(21)84011 70989 (01)00884838055322(21)70989 84109 (01)00884838055322(21)84109 84102 (01)00884838055322(21)84102 84238 (01)00884838055322(21)84238 84199 (01)00884838055322(21)84199 84224 (01)00884838055322(21)84224 84248 (01)00884838055322(21)84248 84226 (01)00884838055322(21)84226 84250 (01)00884838055322(21)84250 84341 (01)00884838055322(21)84341 84271 (01)00884838055322(21)84271 84409 N/A 84473 (01)00884838055322(21)84473 84474 (01)00884838055322(21)84474 84533 (01)00884838055322(21)84533 84517 (01)00884838055322(21)84517 84528 (01)00884838055322(21)84528 84437 (01)00884838055322(21)84437 84490 (01)00884838055322(21)84490 84546 (01)00884838055322(21)84546 84560 (01)00884838055322(21)84560 84435 (01)00884838055322(21)84435 84550 (01)00884838055322(21)84550 84459 (01)00884838055322(21)84459 84516 (01)00884838055322(21)84516 84554 (01)00884838055322(21)84554 84569 (01)00884838055322(21)84569 84671 (01)00884838055322(21)84671 84630 (01)00884838055322(21)84630 84681 (01)00884838055322(21)84681 84850 (01)00884838055322(21)84850 84867 (01)00884838055322(21)84867 84910 (01)00884838055322(21)84910 84807 (01)00884838055322(21)84807 84920 (01)00884838055322(21)84920 84825 (01)00884838055322(21)84825 87076 (01)00884838055322(21)87076 84921 (01)00884838055322(21)84921 70401 N/A 70301 N/A 70093 N/A 70144 N/A 70148 N/A 70191 N/A 70297 N/A 70245 N/A 70316 N/A 70451 N/A 70453 N/A 70482 N/A 70429 N/A 70608 N/A 70440 N/A 70472 N/A 70587 N/A 70465 N/A 70770 N/A 70872 N/A 70887 N/A 70843 N/A 70761 N/A 70899 N/A 70906 N/A 70923 N/A 70994 N/A 84005 N/A 84038 N/A 84068 (01)00884838055322(21)84068 84085 (01)00884838055322(21)84085 84137 (01)00884838055322(21)84137 70914 (01)00884838055322(21)70914 84154 (01)00884838055322(21)84154 84208 (01)00884838055322(21)84208 84252 (01)00884838055322(21)84252 84185 (01)00884838055322(21)84185 84253 (01)00884838055322(21)84253 84297 (01)00884838055322(21)84297 84293 (01)00884838055322(21)84293 84231 (01)00884838055322(21)84231 84210 (01)00884838055322(21)84210 84306 (01)00884838055322(21)84306 84392 (01)00884838055322(21)84392 84377 (01)00884838055322(21)84377 84295 (01)00884838055322(21)84295 84448 (01)00884838055322(21)84448 84406 (01)00884838055322(21)84406 84334 (01)00884838055322(21)84334 84346 (01)00884838055322(21)84346 84445 (01)00884838055322(21)84445 84325 (01)00884838055322(21)84325 84429 (01)00884838055322(21)84429 84450 (01)00884838055322(21)84450 84694 (01)00884838055322(21)84694 84690 (01)00884838055322(21)84690 84768 (01)00884838055322(21)84768 84803 (01)00884838055322(21)84803 84838 (01)00884838055322(21)84838 84272 (01)00884838055322(21)84272 84869 (01)00884838055322(21)84869 84750 (01)00884838055322(21)84750 87081 (01)00884838055322(21)87081 87083 (01)00884838055322(21)87083 87121 (01)00884838055322(21)87121 87195 (01)00884838055322(21)87195 87194 (01)00884838055322(21)87194 87228 (01)00884838055322(21)87228 70760 N/A 87186 (01)00884838055322(21)87186 70599 N/A 84801 (01)00884838055322(21)84801 84900 (01)00884838055322(21)84900 84901 (01)00884838055322(21)84901 70347 N/A 70648 N/A 70797 N/A 84047 N/A 84489 (01)00884838055322(21)84489 84581 (01)00884838055322(21)84581 84789 (01)00884838055322(21)84789 87059 (01)00884838055322(21)87059 87111 (01)00884838055322(21)87111 70654 N/A 84792 (01)00884838055322(21)84792 70804 N/A 84806 (01)00884838055322(21)84806 84218 (01)00884838055322(21)84218 70072 N/A 70613 N/A 70934 N/A 70146 N/A 70201 N/A 70287 N/A 70281 N/A 70658 N/A 70645 N/A 70751 N/A 70880 N/A 84015 N/A 84212 (01)00884838055322(21)84212 84267 (01)00884838055322(21)84267 87068 (01)00884838055322(21)87068 70119 N/A 70280 N/A 70339 N/A 70361 N/A 70425 N/A 70717 N/A 70773 N/A 70933 N/A 70931 N/A 70932 N/A 70962 N/A 84095 (01)00884838055322(21)84095 84096 (01)00884838055322(21)84096 84070 (01)00884838055322(21)84070 84241 (01)00884838055322(21)84241 84245 (01)00884838055322(21)84245 84292 (01)00884838055322(21)84292 84298 (01)00884838055322(21)84298 84401 (01)00884838055322(21)84401 84372 (01)00884838055322(21)84372 84421 (01)00884838055322(21)84421 84375 N/A 84524 (01)00884838055322(21)84524 84523 (01)00884838055322(21)84523 84518 (01)00884838055322(21)84518 84520 (01)00884838055322(21)84520 84374 N/A 84680 (01)00884838055322(21)84680 84676 (01)00884838055322(21)84676 84455 (01)00884838055322(21)84455 84678 (01)00884838055322(21)84678 84598 (01)00884838055322(21)84598 84679 (01)00884838055322(21)84679 84693 (01)00884838055322(21)84693 84522 (01)00884838055322(21)84522 84757 (01)00884838055322(21)84757 84458 (01)00884838055322(21)84458 84677 (01)00884838055322(21)84677 84519 (01)00884838055322(21)84519 84657 (01)00884838055322(21)84657 84521 (01)00884838055322(21)84521 84832 (01)00884838055322(21)84832 87000 (01)00884838055322(21)87000 84456 (01)00884838055322(21)84456 84477 (01)00884838055322(21)84477 87155 (01)00884838055322(21)87155 87131 (01)00884838055322(21)87131 87129 (01)00884838055322(21)87129 87213 (01)00884838055322(21)87213 70196 N/A 70334 N/A 70335 N/A 70703 N/A 70384 N/A 70918 N/A 70919 N/A 84216 (01)00884838055322(21)84216 84211 (01)00884838055322(21)84211 84209 (01)00884838055322(21)84209 84261 (01)00884838055322(21)84261 84331 (01)00884838055322(21)84331 84494 (01)00884838055322(21)84494 84719 (01)00884838055322(21)84719 84720 (01)00884838055322(21)84720 84617 N/A 70423 N/A 70069 N/A 70027 N/A 70103 N/A 70102 N/A 70227 N/A 70290 N/A 70304 N/A 70300 N/A 70256 N/A 70444 N/A 70483 N/A 70639 N/A 70585 N/A 70687 N/A 70644 N/A 70592 N/A 70671 N/A 70591 N/A 70726 N/A 70480 N/A 70728 N/A 70642 N/A 70746 N/A 70786 N/A 70750 N/A 70757 N/A 70795 N/A 70765 N/A 70798 N/A 70817 N/A 70809 N/A 70834 N/A 70823 N/A 70821 N/A 70702 N/A 70935 N/A 70946 N/A 70961 N/A 70971 N/A 70826 N/A 70988 N/A 84017 N/A 84041 (01)00884838055322(21)84041 84007 (01)00884838055322(21)84007 84076 (01)00884838055322(21)84076 84097 (01)00884838055322(21)84097 84080 (01)00884838055322(21)84080 84135 (01)00884838055322(21)84135 84091 (01)00884838055322(21)84091 84081 (01)00884838055322(21)84081 84083 (01)00884838055322(21)84083 84177 (01)00884838055322(21)84177 70957 (01)00884838055322(21)70957 84127 (01)00884838055322(21)84127 84125 (01)00884838055322(21)84125 84124 (01)00884838055322(21)84124 84220 (01)00884838055322(21)84220 84269 (01)00884838055322(21)84269 84294 (01)00884838055322(21)84294 84368 (01)00884838055322(21)84368 84382 (01)00884838055322(21)84382 84413 (01)00884838055322(21)84413 84420 (01)00884838055322(21)84420 84281 (01)00884838055322(21)84281 84431 (01)00884838055322(21)84431 84144 (01)00884838055322(21)84144 84329 (01)00884838055322(21)84329 84491 (01)00884838055322(21)84491 84502 (01)00884838055322(21)84502 84513 (01)00884838055322(21)84513 84507 (01)00884838055322(21)84507 84530 (01)00884838055322(21)84530 84536 (01)00884838055322(21)84536 84606 (01)00884838055322(21)84606 84541 (01)00884838055322(21)84541 84594 (01)00884838055322(21)84594 84604 (01)00884838055322(21)84604 84804 (01)00884838055322(21)84804 84864 (01)00884838055322(21)84864 84871 (01)00884838055322(21)84871 84952 (01)00884838055322(21)84952 84851 (01)00884838055322(21)84851 84893 (01)00884838055322(21)84893 84988 (01)00884838055322(21)84988 84995 (01)00884838055322(21)84995 87165 (01)00884838055322(21)87165 87092 (01)00884838055322(21)87092 87115 (01)00884838055322(21)87115 84956 (01)00884838055322(21)84956 84275 (01)00884838055322(21)84275 84826 (01)00884838055322(21)84826 84940 (01)00884838055322(21)84940 87210 (01)00884838055322(21)87210 84086 (01)00884838055322(21)84086 70038 N/A 70056 N/A 70037 N/A 70036 N/A 70011 N/A 70013 N/A 70039 N/A 70053 N/A 70055 N/A 70122 N/A 70084 N/A 70142 N/A 70192 N/A 70203 N/A 70263 N/A 70299 N/A 70329 N/A 70273 N/A 70379 N/A 70436 N/A 70441 N/A 70460 N/A 70454 N/A 70595 N/A 70484 N/A 70432 N/A 70670 N/A 70649 N/A 70682 N/A 70732 N/A 70734 N/A 70741 N/A 70647 N/A 70720 N/A 70735 N/A 70736 N/A 70792 N/A 70774 N/A 70747 N/A 70800 N/A 70789 N/A 70813 N/A 70805 N/A 70772 N/A 70827 N/A 70839 N/A 70824 N/A 70820 N/A 70825 N/A 70848 N/A 70859 N/A 70902 N/A 70836 N/A 70850 N/A 70876 N/A 70909 N/A 70920 N/A 70970 N/A 70926 N/A 84008 N/A 84027 N/A 84034 N/A 70979 (01)00884838055322(21)70979 84031 N/A 84018 N/A 84028 N/A 84052 N/A 84048 N/A 84035 (01)00884838055322(21)84035 84099 (01)00884838055322(21)84099 70861 (01)00884838055322(21)70861 84061 (01)00884838055322(21)84061 84062 (01)00884838055322(21)84062 84065 (01)00884838055322(21)84065 84032 (01)00884838055322(21)84032 84079 (01)00884838055322(21)84079 84172 (01)00884838055322(21)84172 84118 (01)00884838055322(21)84118 84162 (01)00884838055322(21)84162 84060 (01)00884838055322(21)84060 84201 (01)00884838055322(21)84201 84149 (01)00884838055322(21)84149 84193 (01)00884838055322(21)84193 84229 (01)00884838055322(21)84229 84233 (01)00884838055322(21)84233 84114 (01)00884838055322(21)84114 84247 (01)00884838055322(21)84247 84219 (01)00884838055322(21)84219 84194 (01)00884838055322(21)84194 84255 (01)00884838055322(21)84255 84266 (01)00884838055322(21)84266 84270 (01)00884838055322(21)84270 84309 (01)00884838055322(21)84309 84289 (01)00884838055322(21)84289 84379 (01)00884838055322(21)84379 84360 (01)00884838055322(21)84360 84333 (01)00884838055322(21)84333 84357 (01)00884838055322(21)84357 84359 (01)00884838055322(21)84359 84376 (01)00884838055322(21)84376 84335 (01)00884838055322(21)84335 84415 (01)00884838055322(21)84415 84394 (01)00884838055322(21)84394 84444 (01)00884838055322(21)84444 84510 (01)00884838055322(21)84510 84534 (01)00884838055322(21)84534 84480 (01)00884838055322(21)84480 84495 (01)00884838055322(21)84495 84500 (01)00884838055322(21)84500 84501 (01)00884838055322(21)84501 84447 (01)00884838055322(21)84447 84659 N/A 84527 (01)00884838055322(21)84527 84660 N/A 84492 (01)00884838055322(21)84492 84535 (01)00884838055322(21)84535 84545 (01)00884838055322(21)84545 84191 (01)00884838055322(21)84191 84556 (01)00884838055322(21)84556 84641 (01)00884838055322(21)84641 84603 (01)00884838055322(21)84603 84650 (01)00884838055322(21)84650 84634 (01)00884838055322(21)84634 84635 (01)00884838055322(21)84635 84722 (01)00884838055322(21)84722 84666 (01)00884838055322(21)84666 84724 (01)00884838055322(21)84724 84713 (01)00884838055322(21)84713 84706 (01)00884838055322(21)84706 84708 (01)00884838055322(21)84708 84721 (01)00884838055322(21)84721 84647 (01)00884838055322(21)84647 84697 (01)00884838055322(21)84697 84670 (01)00884838055322(21)84670 84712 (01)00884838055322(21)84712 84747 (01)00884838055322(21)84747 84790 (01)00884838055322(21)84790 84751 (01)00884838055322(21)84751 84583 (01)00884838055322(21)84583 84748 (01)00884838055322(21)84748 84714 (01)00884838055322(21)84714 84793 (01)00884838055322(21)84793 84820 (01)00884838055322(21)84820 84880 (01)00884838055322(21)84880 84839 (01)00884838055322(21)84839 84818 (01)00884838055322(21)84818 84819 (01)00884838055322(21)84819 84858 (01)00884838055322(21)84858 84873 (01)00884838055322(21)84873 84745 (01)00884838055322(21)84745 84879 (01)00884838055322(21)84879 84895 (01)00884838055322(21)84895 84904 (01)00884838055322(21)84904 84775 (01)00884838055322(21)84775 84987 (01)00884838055322(21)84987 84918 (01)00884838055322(21)84918 84930 (01)00884838055322(21)84930 84977 (01)00884838055322(21)84977 84978 (01)00884838055322(21)84978 84908 (01)00884838055322(21)84908 87001 (01)00884838055322(21)87001 87038 (01)00884838055322(21)87038 84805 (01)00884838055322(21)84805 87023 (01)00884838055322(21)87023 87066 (01)00884838055322(21)87066 87117 (01)00884838055322(21)87117 87026 (01)00884838055322(21)87026 87196 (01)00884838055322(21)87196 87197 (01)00884838055322(21)87197 87136 (01)00884838055322(21)87136 87175 (01)00884838055322(21)87175 87204 (01)00884838055322(21)87204 87235 (01)00884838055322(21)87235 87176 (01)00884838055322(21)87176 87187 (01)00884838055322(21)87187 87234 (01)00884838055322(21)87234 70343 N/A 70346 N/A 70402 N/A 84396 N/A 70891 N/A 84354 (01)00884838055322(21)84354 84349 (01)00884838055322(21)84349 84355 N/A 84351 N/A 84352 N/A 84350 (01)00884838055322(21)84350 84353 N/A 84612 (01)00884838055322(21)84612 84661 (01)00884838055322(21)84661 84847 (01)00884838055322(21)84847 87079 (01)00884838055322(21)87079 70261 N/A 70238 N/A 70128 N/A 70198 N/A 87212 (01)00884838055322(21)87212 70193 N/A 70485 N/A 70833 N/A 70831 N/A 84395 (01)00884838055322(21)84395 84404 (01)00884838055322(21)84404 84716 (01)00884838055322(21)84716 84025 (01)00884838055322(21)84025 84347 (01)00884838055322(21)84347 84772 (01)00884838055322(21)84772 84854 (01)00884838055322(21)84854 87037 (01)00884838055322(21)87037 87036 (01)00884838055322(21)87036 84443 (01)00884838055322(21)84443 84852 (01)00884838055322(21)84852 70318 N/A 70967 N/A 70930 N/A 70264 N/A 84089 (01)00884838055322(21)84089 84319 (01)00884838055322(21)84319 84221 N/A 84430 (01)00884838055322(21)84430 84600 (01)00884838055322(21)84600 84572 (01)00884838055322(21)84572 84602 (01)00884838055322(21)84602 84571 (01)00884838055322(21)84571 84700 (01)00884838055322(21)84700 84862 (01)00884838055322(21)84862 84983 (01)00884838055322(21)84983 84885 (01)00884838055322(21)84885 84834 N/A 70941 N/A 70285 N/A 70262 N/A 70638 N/A 70637 N/A 70714 N/A 70615 N/A 70862 N/A 70896 N/A 70990 N/A 70998 (01)00884838055322(21)70998 84130 (01)00884838055322(21)84130 84140 (01)00884838055322(21)84140 84138 (01)00884838055322(21)84138 84217 (01)00884838055322(21)84217 84278 (01)00884838055322(21)84278 84370 (01)00884838055322(21)84370 84419 (01)00884838055322(21)84419 84398 (01)00884838055322(21)84398 84733 (01)00884838055322(21)84733 70257 N/A 70018 N/A 70059 N/A 70303 N/A 70439 N/A 70922 N/A 70947 N/A 70960 (01)00884838055322(21)70960 84148 (01)00884838055322(21)84148 84115 (01)00884838055322(21)84115 84587 (01)00884838055322(21)84587 84752 (01)00884838055322(21)84752 87143 (01)00884838055322(21)87143 87144 (01)00884838055322(21)87144 70777 N/A 70075 N/A 70360 N/A 70131 N/A 70628 N/A 70481 N/A 70722 N/A 84145 (01)00884838055322(21)84145 84611 (01)00884838055322(21)84611 70828 N/A 84057 (01)00884838055322(21)84057 84288 (01)00884838055322(21)84288 84424 (01)00884838055322(21)84424 70136 N/A 70882 N/A 84045 N/A 84046 N/A 70022 N/A 70155 N/A 70437 N/A 70775 N/A 70830 N/A 84029 N/A 84363 (01)00884838055322(21)84363 84648 (01)00884838055322(21)84648 84605 (01)00884838055322(21)84605 84573 (01)00884838055322(21)84573 84689 (01)00884838055322(21)84689 87003 (01)00884838055322(21)87003 87102 (01)00884838055322(21)87102 70371 N/A 70236 (01)00884838055322(21)70236 70271 N/A 70937 N/A 84067 N/A 84682 (01)00884838055322(21)84682 84709 (01)00884838055322(21)84709 70048 N/A 70065 N/A 70066 N/A 70255 N/A 70711 N/A 87078 (01)00884838055322(21)87078 70282 N/A 84113 (01)00884838055322(21)84113 84888 (01)00884838055322(21)84888 70910 N/A 70416 N/A 70945 N/A 84129 (01)00884838055322(21)84129 87116 (01)00884838055322(21)87116 70759 N/A 70140 N/A 70350 N/A 70337 N/A 70351 N/A 70357 N/A 70368 N/A 70449 N/A 70456 N/A 70489 N/A 70486 N/A 70490 N/A 70686 N/A 70624 N/A 70745 N/A 70487 N/A 70744 N/A 70428 (01)00884838055322(21)70428 70847 N/A 70811 N/A 70900 N/A 70815 N/A 70840 N/A 70985 (01)00884838055322(21)70985 70954 N/A 84039 (01)00884838055322(21)84039 84171 (01)00884838055322(21)84171 84198 (01)00884838055322(21)84198 84069 (01)00884838055322(21)84069 84021 (01)00884838055322(21)84021 84244 (01)00884838055322(21)84244 84142 (01)00884838055322(21)84142 84279 (01)00884838055322(21)84279 84305 (01)00884838055322(21)84305 84361 (01)00884838055322(21)84361 84362 (01)00884838055322(21)84362 84626 (01)00884838055322(21)84626 84599 (01)00884838055322(21)84599 84662 (01)00884838055322(21)84662 84637 (01)00884838055322(21)84637 84726 (01)00884838055322(21)84726 84729 (01)00884838055322(21)84729 84738 (01)00884838055322(21)84738 84758 (01)00884838055322(21)84758 84717 (01)00884838055322(21)84717 84759 (01)00884838055322(21)84759 84796 (01)00884838055322(21)84796 84428 (01)00884838055322(21)84428 84865 (01)00884838055322(21)84865 84653 (01)00884838055322(21)84653 84931 (01)00884838055322(21)84931 84934 (01)00884838055322(21)84934 87031 (01)00884838055322(21)87031 84975 (01)00884838055322(21)84975 87024 (01)00884838055322(21)87024 84989 (01)00884838055322(21)84989 87069 (01)00884838055322(21)87069 87147 (01)00884838055322(21)87147 87188 (01)00884838055322(21)87188 87185 (01)00884838055322(21)87185 87071 (01)00884838055322(21)87071 87153 (01)00884838055322(21)87153 87154 (01)00884838055322(21)87154 87067 (01)00884838055322(21)87067 87208 (01)00884838055322(21)87208 87172 (01)00884838055322(21)87172 87211 (01)00884838055322(21)87211 87152 (01)00884838055322(21)87152 87237 (01)00884838055322(21)87237 87244 (01)00884838055322(21)87244 87161 N/A 87265 (01)00884838055322(21)87265 70092 N/A 70194 N/A 70314 N/A 70242 N/A 70776 N/A 70806 N/A 70697 N/A 70888 N/A 84087 (01)00884838055322(21)84087 70871 (01)00884838055322(21)70871 84258 (01)00884838055322(21)84258 84472 (01)00884838055322(21)84472 70878 (01)00884838055322(21)70878 84613 (01)00884838055322(21)84613 84798 (01)00884838055322(21)84798 84802 (01)00884838055322(21)84802 84746 (01)00884838055322(21)84746 87049 (01)00884838055322(21)87049 87044 (01)00884838055322(21)87044 87035 (01)00884838055322(21)87035 87090 (01)00884838055322(21)87090 87082 (01)00884838055322(21)87082 87093 (01)00884838055322(21)87093 70026 N/A 70652 N/A 70829 N/A 70995 (01)00884838055322(21)70995 70996 (01)00884838055322(21)70996 70953 (01)00884838055322(21)70953 70952 (01)00884838055322(21)70952 84470 (01)00884838055322(21)84470 84276 (01)00884838055322(21)84276 70685 N/A 84369 (01)00884838055322(21)84369 70405 N/A 70982 N/A 70915 N/A 84933 (01)00884838055322(21)84933 70230 N/A 70841 (01)00884838055322(21)70841 84206 (01)00884838055322(21)84206 84214 (01)00884838055322(21)84214 84308 (01)00884838055322(21)84308 84416 (01)00884838055322(21)84416 84482 (01)00884838055322(21)84482 84479 (01)00884838055322(21)84479 84558 (01)00884838055322(21)84558 84620 N/A 84656 (01)00884838055322(21)84656 84808 N/A 84809 (01)00884838055322(21)84809 84848 (01)00884838055322(21)84848 70356 N/A 70677 N/A 70358 N/A 70359 N/A 70057 N/A 70080 N/A 70087 N/A 70097 N/A 70157 N/A 70610 N/A 70693 N/A 70810 N/A 84002 N/A 84003 N/A 84074 N/A 84237 (01)00884838055322(21)84237 84239 (01)00884838055322(21)84239 84338 (01)00884838055322(21)84338 84339 (01)00884838055322(21)84339 84367 (01)00884838055322(21)84367 84483 (01)00884838055322(21)84483 84529 (01)00884838055322(21)84529 84767 (01)00884838055322(21)84767 84849 (01)00884838055322(21)84849 84913 (01)00884838055322(21)84913 84915 (01)00884838055322(21)84915 84969 (01)00884838055322(21)84969 87022 (01)00884838055322(21)87022 84960 (01)00884838055322(21)84960 87095 (01)00884838055322(21)87095 87087 (01)00884838055322(21)87087 87094 (01)00884838055322(21)87094 87086 (01)00884838055322(21)87086 87158 (01)00884838055322(21)87158 87163 (01)00884838055322(21)87163 87259 (01)00884838055322(21)87259 70058 N/A 70225 N/A 70426 N/A 70468 N/A 70791 N/A 70849 N/A 84037 N/A 84036 (01)00884838055322(21)84036 84380 (01)00884838055322(21)84380 84633 (01)00884838055322(21)84633 84616 (01)00884838055322(21)84616 84651 (01)00884838055322(21)84651 84828 (01)00884838055322(21)84828 84827 (01)00884838055322(21)84827 84868 (01)00884838055322(21)84868 87226 (01)00884838055322(21)87226 84575 (01)00884838055322(21)84575 87209 (01)00884838055322(21)87209 70044 N/A 70049 N/A 70060 N/A 70052 N/A 70051 N/A 70042 N/A 70094 N/A 70050 N/A 70076 N/A 70062 N/A 70095 N/A 70063 N/A 70124 N/A 70135 N/A 70190 N/A 70195 N/A 70156 N/A 70061 N/A 70200 (01)00884838055322(21)70200 70260 N/A 70298 N/A 70259 N/A 70328 N/A 70308 N/A 70331 N/A 70292 N/A 70403 N/A 70438 N/A 70442 N/A 70447 N/A 70445 N/A 70619 N/A 70606 N/A 70455 N/A 70473 N/A 70636 N/A 70635 N/A 70627 N/A 70616 N/A 70676 N/A 70621 N/A 70659 N/A 70614 N/A 70699 N/A 70698 N/A 70672 N/A 70700 N/A 70695 N/A 70661 N/A 70694 N/A 70443 N/A 70724 N/A 70650 N/A 70675 N/A 70719 N/A 70758 N/A 70701 N/A 70707 N/A 70727 N/A 70706 N/A 70743 N/A 70749 N/A 70783 N/A 70762 N/A 70690 N/A 70788 N/A 70674 N/A 70769 N/A 70752 N/A 70819 N/A 70715 N/A 70808 N/A 70793 N/A 70779 N/A 70729 N/A 70646 N/A 70898 N/A 70863 N/A 70771 N/A 70835 N/A 70875 N/A 70939 N/A 70801 N/A 70894 N/A 70903 N/A 70951 N/A 70904 N/A 70857 N/A 70972 N/A 70928 N/A 70874 N/A 70893 N/A 70892 N/A 70925 N/A 70983 N/A 70911 N/A 84013 N/A 70963 N/A 84012 (01)00884838055322(21)84012 70977 N/A 70949 N/A 84063 (01)00884838055322(21)84063 84043 (01)00884838055322(21)84043 84075 (01)00884838055322(21)84075 84049 (01)00884838055322(21)84049 84077 (01)00884838055322(21)84077 84134 (01)00884838055322(21)84134 84155 (01)00884838055322(21)84155 70897 (01)00884838055322(21)70897 84181 (01)00884838055322(21)84181 84174 (01)00884838055322(21)84174 84173 (01)00884838055322(21)84173 84157 (01)00884838055322(21)84157 84168 (01)00884838055322(21)84168 84186 (01)00884838055322(21)84186 84169 (01)00884838055322(21)84169 84189 (01)00884838055322(21)84189 84184 (01)00884838055322(21)84184 84170 (01)00884838055322(21)84170 84192 (01)00884838055322(21)84192 84196 (01)00884838055322(21)84196 84225 (01)00884838055322(21)84225 84240 (01)00884838055322(21)84240 84147 (01)00884838055322(21)84147 84254 (01)00884838055322(21)84254 84222 (01)00884838055322(21)84222 84282 (01)00884838055322(21)84282 84088 (01)00884838055322(21)84088 84280 (01)00884838055322(21)84280 84264 (01)00884838055322(21)84264 84274 (01)00884838055322(21)84274 84316 (01)00884838055322(21)84316 84200 (01)00884838055322(21)84200 84286 (01)00884838055322(21)84286 84344 (01)00884838055322(21)84344 84243 (01)00884838055322(21)84243 84340 (01)00884838055322(21)84340 84410 (01)00884838055322(21)84410 84432 (01)00884838055322(21)84432 84400 (01)00884838055322(21)84400 84434 (01)00884838055322(21)84434 84026 (01)00884838055322(21)84026 84439 (01)00884838055322(21)84439 84469 (01)00884838055322(21)84469 84499 (01)00884838055322(21)84499 84403 (01)00884838055322(21)84403 84460 (01)00884838055322(21)84460 84475 (01)00884838055322(21)84475 84440 (01)00884838055322(21)84440 84462 (01)00884838055322(21)84462 84506 (01)00884838055322(21)84506 84509 (01)00884838055322(21)84509 84283 (01)00884838055322(21)84283 84481 (01)00884838055322(21)84481 84537 (01)00884838055322(21)84537 84508 (01)00884838055322(21)84508 84446 (01)00884838055322(21)84446 84441 (01)00884838055322(21)84441 84484 (01)00884838055322(21)84484 84485 (01)00884838055322(21)84485 84433 (01)00884838055322(21)84433 84436 (01)00884838055322(21)84436 84526 (01)00884838055322(21)84526 84467 (01)00884838055322(21)84467 84552 (01)00884838055322(21)84552 84614 (01)00884838055322(21)84614 84512 (01)00884838055322(21)84512 84538 (01)00884838055322(21)84538 84514 (01)00884838055322(21)84514 84627 (01)00884838055322(21)84627 84628 (01)00884838055322(21)84628 84505 (01)00884838055322(21)84505 84642 (01)00884838055322(21)84642 84646 (01)00884838055322(21)84646 84498 (01)00884838055322(21)84734 84674 (01)00884838055322(21)84674 84734 (01)00884838055322(21)84498 84741 (01)00884838055322(21)84741 84811 (01)00884838055322(21)84811 84784 (01)00884838055322(21)84784 84791 (01)00884838055322(21)84791 84816 (01)00884838055322(21)84816 84821 (01)00884838055322(21)84821 84889 (01)00884838055322(21)84889 84874 (01)00884838055322(21)84874 84836 (01)00884838055322(21)84836 84911 (01)00884838055322(21)84911 84824 (01)00884838055322(21)84824 84823 (01)00884838055322(21)84823 84935 (01)00884838055322(21)84935 84853 (01)00884838055322(21)84853 84866 (01)00884838055322(21)84866 84954 (01)00884838055322(21)84954 84929 (01)00884838055322(21)84929 84979 (01)00884838055322(21)84979 84942 (01)00884838055322(21)84942 84970 (01)00884838055322(21)84970 84993 (01)00884838055322(21)84993 87057 (01)00884838055322(21)87057 84973 (01)00884838055322(21)84973 87103 (01)00884838055322(21)87103 87017 (01)00884838055322(21)87017 87043 (01)00884838055322(21)87043 87133 (01)00884838055322(21)87133 87055 (01)00884838055322(21)87055 87132 (01)00884838055322(21)87132 87097 (01)00884838055322(21)87097 87120 (01)00884838055322(21)87120 87019 (01)00884838055322(21)87019 87218 (01)00884838055322(21)87218 87231 (01)00884838055322(21)87231 84314 N/A 84799 N/A 84894 N/A 70179 N/A 70883 N/A 84251 (01)00884838055322(21)84251 84284 (01)00884838055322(21)84284 84776 (01)00884838055322(21)84776 84778 (01)00884838055322(21)84778 84779 (01)00884838055322(21)84779 84781 (01)00884838055322(21)84781 84780 (01)00884838055322(21)84780 84782 (01)00884838055322(21)84782 84783 (01)00884838055322(21)84783 84777 (01)00884838055322(21)84777 70657 N/A 70154 N/A 70710 N/A 84916 (01)00884838055322(21)84916 87232 (01)00884838055322(21)87232 70025 N/A 70434 N/A 70689 N/A 70802 N/A 84402 (01)00884838055322(21)84402 84577 (01)00884838055322(21)84577 84675 (01)00884838055322(21)84675 Model: 781396 41146 Unique Device Identifier (UDI#)-N/A 41318 41472 41564 41176 41175 41253 41282 41492 41485 41026 41132 41130 41200 41398 41061 41007 41039 41157 41181 41127 41262 41256 41350 41378 41510 41541 41567 41012 41505 41230 41268 41186 41359 41441 41459 41460 41271 41521 41556 41584 41236 41302 41343 41204 41449 41011 41138 41259 41440 41531 41151 41524 41518 41297 41595 41610 41612 41615 41617 41619 41618 41509 41591 41103 41105 41043 41010 41085 41024 41029 41016 41052 41031 41055 41071 41119 41017 41125 41025 41112 41051 41141 41139 41192 41084 41145 41160 41211 41142 41210 41227 41131 41218 41240 41286 41284 41283 41288 41349 41144 41266 41239 41261 41368 41375 41338 41373 41402 41390 41228 41327 41367 41412 41432 41433 41395 41383 41454 41389 41388 41392 41442 41381 41380 41417 41471 41424 41473 41143 41538 41561 41553 41235 41045 41118 41314 41397 41108 41366 41519 41436 41070 41330 41465 41470 41491 41172 41162 41255 41254 41446 41515 41047 41020 41114 41169 41168 41196 41260 41178 41351 41363 41498 41464 41520 41500 41523 41522 41088 41089 41041 41054 41226 41287 41328 41336 41384 41387 41355 41334 41423 41189 41371 41376 41335 41453 41548 41573 41038 41480 41050 41113 41096 41086 41087 41093 41129 41184 41163 41161 41213 41201 41202 41217 41220 41193 41234 41233 41246 41257 41258 41267 41310 41199 41337 41332 41344 41352 41399 41365 41411 41422 41469 41474 41499 41489 41502 41494 41545 41568 41574 41535 41074 41068 41042 41060 41049 41064 41106 41133 41109 41124 41126 41164 41153 41174 41128 41136 41244 41275 41243 41272 41290 41281 41280 41292 41298 41117 41299 41329 41339 41229 41361 41357 41362 41428 41408 41452 41457 41496 41437 41435 41488 41493 41513 41400 41543 41544 41549 41507 41559 41490 41570 41565 41572 41534 41558 41571 41099 41182 41232 41231 41497 41547 41563 41300 41583 41592 41115 41405 41180 41185 41293 41458 41466 41467 41560 41001 41013 41100 41008 41140 41187 41191 41225 41190 41214 41249 41456 41413 41461 41450 41301 41033 41080 41167 41216 41215 41486 41364 41372 41304 41527 41340 41289 41075 41306 41540 41562 41107 41152 41219 41296 41331 41309 41394 41546 41575 41588 41120 41137 41111 41110 41295 41594 41407 41177 41179 41241 41279 41578 41478 41577 41155 41419 41536 41069 41021 41000 41036 41037 41044 41005 41006 41059 41066 41067 41009 41083 41035 41028 41090 41034 41095 41023 41015 41077 41022 41057 41048 41018 41056 41046 41091 41073 41116 41097 41104 41079 41149 41092 41123 41098 41159 41154 41158 41173 41094 41188 41148 41166 41171 41205 41206 41198 41212 41208 41134 41197 41203 41195 41194 41250 41242 41209 41221 41251 41237 41263 41303 41222 41312 41313 41265 41278 41291 41370 41342 41294 41311 41406 41354 41438 41418 41427 41358 41425 41426 41356 41475 41434 41415 41420 41277 41444 41421 41462 41495 41512 41409 41463 41516 41429 41482 41305 41511 41525 41517 41484 41514 41532 41551 41481 41552 41580 41569 41555 41590 41238 41224 41319 41526 41082 41414 41479 41476 41477
Recalling Firm/
Manufacturer
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
FDA Determined
Cause 2
Device Design
Action Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take: Philips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function. A Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is detected in the HDU, the Philips FSE will replace the necessary mechanical component(s) to resolve the issue. If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377) and reference FCO78100527.
Quantity in Commerce 1517 units, 488 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS HEALTHCARE
-
-