| |
Class 2 Device Recall Philips |
 |
| Date Initiated by Firm |
August 11, 2021 |
| Create Date |
September 03, 2021 |
| Recall Status1 |
Completed |
| 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.
|
| 510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = PHILIPS HEALTHCARE
|
|
|
|
