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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  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-2417-2021
Recall Event ID 88491
510(K)Number K163116  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia 3.0T-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:
781342
781377

Code Information Serial Number Unique Device Identifier (UDI#) Model: 781342 71352 N/A 71426 N/A 71977 (01)00884838055339(21)71977 85020 (01)00884838055339(21)85020 85106 (01)00884838055339(21)85106 71011 N/A 71152 N/A 71526 N/A 71433 (01)00884838055339(21)71433 71710 (01)00884838055339(21)71710 71817 (01)00884838055339(21)71817 71812 (01)00884838055339(21)71812 71403 (01)00884838055339(21)71403 71311 N/A 71345 N/A 71392 N/A 71395 N/A 71628 N/A 71723 (01)00884838055339(21)71723 85393 (01)00884838055339(21)85393 71042 N/A 71101 N/A 71168 N/A 71179 N/A 71178 N/A 71214 N/A 71252 N/A 71313 N/A 71342 N/A 71328 N/A 71309 N/A 71419 N/A 71453 N/A 71555 N/A 71557 N/A 71550 N/A 71551 N/A 71693 (01)00884838055339(21)71693 71674 (01)00884838055339(21)71674 71733 (01)00884838055339(21)71733 71859 (01)00884838055339(21)71859 71949 (01)00884838055339(21)71949 71993 (01)00884838055339(21)71993 71994 (01)00884838055339(21)71994 85045 (01)00884838055339(21)85045 85036 (01)00884838055339(21)85036 85155 (01)00884838055339(21)85155 85115 (01)00884838055339(21)85115 71602 (01)00884838055339(21)71602 71216 N/A 71651 N/A 71950 (01)00884838055339(21)71950 85208 (01)00884838055339(21)85208 71163 N/A 71408 N/A 71499 N/A 71493 N/A 71541 N/A 71580 N/A 71668 (01)00884838055339(21)71668 71729 (01)00884838055339(21)71729 71771 (01)00884838055339(21)71771 71726 (01)00884838055339(21)71726 71260 N/A 71324 N/A 71276 N/A 71800 (01)00884838055339(21)71800 71068 N/A 71081 N/A 71300 N/A 71481 N/A 71482 N/A 71006 N/A 71018 N/A 71044 N/A 71072 N/A 71040 N/A 71189 N/A 71198 N/A 71197 N/A 71224 N/A 71332 N/A 71320 N/A 71366 N/A 71434 N/A 71442 N/A 71384 N/A 71448 N/A 71487 N/A 71597 N/A 71496 N/A 71623 (01)00884838055339(21)71623 71486 (01)00884838055339(21)71486 71704 (01)00884838055339(21)71704 71749 (01)00884838055339(21)71749 71703 (01)00884838055339(21)71703 71752 (01)00884838055339(21)71752 71706 (01)00884838055339(21)71706 71831 (01)00884838055339(21)71831 71644 (01)00884838055339(21)71644 71645 (01)00884838055339(21)71645 71737 (01)00884838055339(21)71737 71871 (01)00884838055339(21)71871 85081 (01)00884838055339(21)85081 85143 N/A 85142 (01)00884838055339(21)85142 85114 (01)00884838055339(21)85114 71339 N/A 71730 (01)00884838055339(21)71730 71452 N/A 71470 N/A 71468 N/A 71465 N/A 71471 N/A 71492 N/A 71485 N/A 71467 N/A 71480 N/A 71464 N/A 71509 N/A 71520 N/A 71479 N/A 71548 N/A 71514 N/A 71517 N/A 71472 N/A 71505 N/A 71516 N/A 71596 N/A 71497 N/A 71554 N/A 71511 N/A 71588 N/A 71553 N/A 71560 N/A 71601 N/A 71626 N/A 71594 N/A 71614 N/A 71544 (01)00884838055339(21)71544 71624 N/A 71637 N/A 71519 N/A 71621 N/A 71629 N/A 71642 N/A 71473 N/A 71506 N/A 71605 N/A 71653 (01)00884838055339(21)71653 71654 (01)00884838055339(21)71654 71633 (01)00884838055339(21)71633 71692 (01)00884838055339(21)71692 71660 (01)00884838055339(21)71660 71709 (01)00884838055339(21)71709 71708 (01)00884838055339(21)71708 71698 (01)00884838055339(21)71698 71622 (01)00884838055339(21)71622 71699 (01)00884838055339(21)71699 71567 (01)00884838055339(21)71567 71734 (01)00884838055339(21)71734 71755 (01)00884838055339(21)71755 71738 (01)00884838055339(21)71738 71702 (01)00884838055339(21)71702 71765 (01)00884838055339(21)71765 71713 (01)00884838055339(21)71713 71695 (01)00884838055339(21)71695 71784 (01)00884838055339(21)71784 71559 (01)00884838055339(21)71559 71779 (01)00884838055339(21)71779 71788 (01)00884838055339(21)71788 71783 (01)00884838055339(21)71783 71804 (01)00884838055339(21)71804 71818 (01)00884838055339(21)71818 71690 (01)00884838055339(21)71690 71821 (01)00884838055339(21)71821 71814 (01)00884838055339(21)71814 71839 (01)00884838055339(21)71839 71786 (01)00884838055339(21)71786 71866 (01)00884838055339(21)71866 71775 (01)00884838055339(21)71775 71819 (01)00884838055339(21)71819 71856 (01)00884838055339(21)71856 71687 (01)00884838055339(21)71687 71807 (01)00884838055339(21)71807 71855 (01)00884838055339(21)71855 71744 (01)00884838055339(21)71744 71714 (01)00884838055339(21)71714 71875 (01)00884838055339(21)71875 71894 (01)00884838055339(21)71894 71716 (01)00884838055339(21)71716 71707 (01)00884838055339(21)71707 71861 (01)00884838055339(21)71861 71955 (01)00884838055339(21)71955 71820 (01)00884838055339(21)71820 71872 (01)00884838055339(21)71872 71876 (01)00884838055339(21)71876 71928 (01)00884838055339(21)71928 71899 (01)00884838055339(21)71899 71987 (01)00884838055339(21)71987 71917 (01)00884838055339(21)71917 71898 (01)00884838055339(21)71898 71952 (01)00884838055339(21)71952 71935 (01)00884838055339(21)71935 71973 (01)00884838055339(21)71973 71930 (01)00884838055339(21)71930 71782 (01)00884838055339(21)71782 71945 (01)00884838055339(21)71945 85002 (01)00884838055339(21)85002 71840 (01)00884838055339(21)71840 71976 (01)00884838055339(21)71976 71656 (01)00884838055339(21)71656 71868 (01)00884838055339(21)71868 85005 (01)00884838055339(21)85005 71908 (01)00884838055339(21)71908 71745 (01)00884838055339(21)71745 71999 (01)00884838055339(21)71999 71998 (01)00884838055339(21)71998 85000 (01)00884838055339(21)85000 71610 (01)00884838055339(21)71610 71913 (01)00884838055339(21)71913 71887 (01)00884838055339(21)71887 85003 (01)00884838055339(21)85003 71742 (01)00884838055339(21)71742 71951 (01)00884838055339(21)71951 85026 (01)00884838055339(21)85026 85010 (01)00884838055339(21)85010 71988 (01)00884838055339(21)71988 85034 (01)00884838055339(21)85034 71946 (01)00884838055339(21)71946 71958 (01)00884838055339(21)71958 85079 (01)00884838055339(21)85079 71944 (01)00884838055339(21)71944 85097 (01)00884838055339(21)85097 85044 (01)00884838055339(21)85044 85061 (01)00884838055339(21)85061 85047 (01)00884838055339(21)85047 85049 (01)00884838055339(21)85049 71685 (01)00884838055339(21)71685 85089 (01)00884838055339(21)85089 85048 (01)00884838055339(21)85048 85024 (01)00884838055339(21)85024 71909 (01)00884838055339(21)71909 85105 (01)00884838055339(21)85105 85082 (01)00884838055339(21)85082 85095 (01)00884838055339(21)85095 85112 N/A 85096 (01)00884838055339(21)85096 71877 (01)00884838055339(21)71877 85028 (01)00884838055339(21)85028 85080 (01)00884838055339(21)85080 85099 (01)00884838055339(21)85099 85056 (01)00884838055339(21)85056 85146 (01)00884838055339(21)85146 85016 (01)00884838055339(21)85016 85111 (01)00884838055339(21)85111 85075 (01)00884838055339(21)85075 85042 (01)00884838055339(21)85042 71997 (01)00884838055339(21)71997 85073 (01)00884838055339(21)85073 85132 (01)00884838055339(21)85132 85169 (01)00884838055339(21)85169 85162 (01)00884838055339(21)85162 85153 (01)00884838055339(21)85153 85168 (01)00884838055339(21)85168 85037 (01)00884838055339(21)85037 85160 (01)00884838055339(21)85160 85141 (01)00884838055339(21)85141 71922 (01)00884838055339(21)71922 85165 (01)00884838055339(21)85165 85171 (01)00884838055339(21)85171 85157 (01)00884838055339(21)85157 85070 (01)00884838055339(21)85070 85170 N/A 85174 (01)00884838055339(21)85174 85184 (01)00884838055339(21)85184 85050 (01)00884838055339(21)85050 85177 (01)00884838055339(21)85177 85186 (01)00884838055339(21)85186 85098 (01)00884838055339(21)85098 85172 (01)00884838055339(21)85172 85192 (01)00884838055339(21)85192 85197 (01)00884838055339(21)85197 85152 (01)00884838055339(21)85152 85204 (01)00884838055339(21)85204 85226 (01)00884838055339(21)85226 85195 (01)00884838055339(21)85195 85200 (01)00884838055339(21)85200 85215 (01)00884838055339(21)85215 85188 (01)00884838055339(21)85188 85231 (01)00884838055339(21)85231 85237 (01)00884838055339(21)85237 85238 (01)00884838055339(21)85238 85233 (01)00884838055339(21)85233 85243 (01)00884838055339(21)85243 85199 (01)00884838055339(21)85199 71957 (01)00884838055339(21)71957 85234 (01)00884838055339(21)85234 85218 (01)00884838055339(21)85218 85178 N/A 85251 (01)00884838055339(21)85251 85258 (01)00884838055339(21)85258 85219 (01)00884838055339(21)85219 85247 (01)00884838055339(21)85247 85277 (01)00884838055339(21)85277 85230 (01)00884838055339(21)85230 85282 (01)00884838055339(21)85282 85242 (01)00884838055339(21)85242 85272 (01)00884838055339(21)85272 85065 (01)00884838055339(21)85065 85305 (01)00884838055339(21)85305 85198 (01)00884838055339(21)85198 85290 (01)00884838055339(21)85290 85291 (01)00884838055339(21)85291 85310 (01)00884838055339(21)85310 85284 (01)00884838055339(21)85284 85311 (01)00884838055339(21)85311 85313 (01)00884838055339(21)85313 85220 (01)00884838055339(21)85220 85268 (01)00884838055339(21)85268 85300 (01)00884838055339(21)85300 85127 (01)00884838055339(21)85127 85294 (01)00884838055339(21)85294 85285 (01)00884838055339(21)85285 85309 (01)00884838055339(21)85309 85280 (01)00884838055339(21)85280 85288 (01)00884838055339(21)85288 85314 (01)00884838055339(21)85314 85270 (01)00884838055339(21)85270 85325 (01)00884838055339(21)85325 85323 (01)00884838055339(21)85323 85339 (01)00884838055339(21)85339 85283 (01)00884838055339(21)85283 85333 (01)00884838055339(21)85333 85334 (01)00884838055339(21)85334 85303 (01)00884838055339(21)85303 85269 (01)00884838055339(21)85269 85345 (01)00884838055339(21)85345 85351 (01)00884838055339(21)85351 85356 (01)00884838055339(21)85356 85349 (01)00884838055339(21)85349 85350 (01)00884838055339(21)85350 85354 (01)00884838055339(21)85354 85382 (01)00884838055339(21)85382 85362 (01)00884838055339(21)85362 85355 (01)00884838055339(21)85355 85332 (01)00884838055339(21)85332 85336 (01)00884838055339(21)85336 85371 (01)00884838055339(21)85371 85375 (01)00884838055339(21)85375 85380 (01)00884838055339(21)85380 85384 (01)00884838055339(21)85384 85370 (01)00884838055339(21)85370 85389 (01)00884838055339(21)85389 85385 (01)00884838055339(21)85385 85357 (01)00884838055339(21)85357 85335 (01)00884838055339(21)85335 85386 (01)00884838055339(21)85386 85387 (01)00884838055339(21)85387 85398 (01)00884838055339(21)85398 85383 (01)00884838055339(21)85383 85364 (01)00884838055339(21)85364 85390 (01)00884838055339(21)85390 85397 (01)00884838055339(21)85397 85406 (01)00884838055339(21)85406 0 N/A 85402 (01)00884838055339(21)85402 85418 (01)00884838055339(21)85418 85361 (01)00884838055339(21)85361 71609 N/A 71631 N/A 71834 N/A 71918 (01)00884838055339(21)71918 71372 N/A 71649 N/A 71581 (01)00884838055339(21)71581 71582 (01)00884838055339(21)71582 71748 (01)00884838055339(21)71748 71373 N/A 71405 N/A 71406 N/A 71979 (01)00884838055339(21)71979 85265 (01)00884838055339(21)85265 71020 N/A 71025 N/A 71019 N/A 71003 N/A 71084 N/A 71023 N/A 71173 N/A 71192 N/A 71283 N/A 71298 N/A 71337 N/A 71315 N/A 71363 N/A 71288 N/A 71278 N/A 71359 N/A 71440 N/A 71396 N/A 71501 N/A 71370 N/A 71390 N/A 71400 N/A 71603 N/A 71521 N/A 71607 N/A 71590 (01)00884838055339(21)71590 71576 (01)00884838055339(21)71576 71725 (01)00884838055339(21)71725 71773 (01)00884838055339(21)71773 71791 (01)00884838055339(21)71791 71774 (01)00884838055339(21)71774 71874 (01)00884838055339(21)71874 71838 (01)00884838055339(21)71838 71751 (01)00884838055339(21)71751 85031 (01)00884838055339(21)85031 85025 (01)00884838055339(21)85025 85180 (01)00884838055339(21)85180 85161 (01)00884838055339(21)85161 85341 (01)00884838055339(21)85341 85342 (01)00884838055339(21)85342 85319 (01)00884838055339(21)85319 85391 (01)00884838055339(21)85391 71047 N/A 71678 (01)00884838055339(21)71678 71662 (01)00884838055339(21)71662 71891 (01)00884838055339(21)71891 85189 (01)00884838055339(21)85189 71474 N/A 71267 N/A 71402 N/A 71457 N/A 71353 (01)00884838055339(21)71353 71412 N/A 71443 N/A 71650 N/A 71604 (01)00884838055339(21)71604 71689 (01)00884838055339(21)71689 71823 N/A 71896 (01)00884838055339(21)71896 71895 (01)00884838055339(21)71895 71954 (01)00884838055339(21)71954 85059 (01)00884838055339(21)85059 85085 (01)00884838055339(21)85085 85092 (01)00884838055339(21)85092 85087 (01)00884838055339(21)85087 85340 (01)00884838055339(21)85340 71231 N/A 71338 N/A 71418 N/A 71924 (01)00884838055339(21)71924 71051 N/A 71050 N/A 71266 N/A 71439 N/A 71595 N/A 71612 (01)00884838055339(21)71612 71613 (01)00884838055339(21)71613 71815 (01)00884838055339(21)71815 71799 (01)00884838055339(21)71799 71991 (01)00884838055339(21)71991 85011 (01)00884838055339(21)85011 85202 (01)00884838055339(21)85202 85306 N/A 71008 N/A 71215 N/A 71318 N/A 71308 N/A 71354 N/A 71287 N/A 71285 N/A 71459 N/A 71490 N/A 71534 N/A 71754 (01)00884838055339(21)71754 71806 (01)00884838055339(21)71806 85015 (01)00884838055339(21)85015 71962 (01)00884838055339(21)71962 71964 (01)00884838055339(21)71964 71963 (01)00884838055339(21)71963 85101 (01)00884838055339(21)85101 71437 N/A 71504 N/A 71394 N/A 71910 (01)00884838055339(21)71910 85063 (01)00884838055339(21)85063 85183 (01)00884838055339(21)85183 85206 (01)00884838055339(21)85206 85216 (01)00884838055339(21)85216 71334 N/A 71409 N/A 71476 N/A 85023 (01)00884838055339(21)85023 71367 N/A 71545 N/A 71461 N/A 85241 (01)00884838055339(21)85241 85302 (01)00884838055339(21)85302 85348 (01)00884838055339(21)85348 85372 N/A 71423 N/A 71184 N/A 71462 N/A 71619 (01)00884838055339(21)71619 71620 (01)00884838055339(21)71620 71061 N/A 71087 N/A 71106 N/A 71165 N/A 71162 N/A 71181 N/A 71351 N/A 71280 N/A 71389 N/A 71393 N/A 71410 N/A 71428 N/A 71422 N/A 71460 N/A 71477 N/A 71512 N/A 71349 N/A 71357 (01)00884838055339(21)71357 71643 N/A 71691 (01)00884838055339(21)71691 71518 (01)00884838055339(21)71518 71743 N/A 71717 (01)00884838055339(21)71717 71763 (01)00884838055339(21)71763 71762 (01)00884838055339(21)71762 71677 (01)00884838055339(21)71677 71854 (01)00884838055339(21)71854 71842 (01)00884838055339(21)71842 71900 (01)00884838055339(21)71900 71967 (01)00884838055339(21)71967 85122 (01)00884838055339(21)85122 85149 (01)00884838055339(21)85149 85190 (01)00884838055339(21)85190 85147 (01)00884838055339(21)85147 85203 (01)00884838055339(21)85203 71966 N/A 85140 (01)00884838055339(21)85140 85318 (01)00884838055339(21)85318 85210 N/A 85347 N/A 71164 N/A 71177 N/A 71326 N/A 71424 N/A 71639 (01)00884838055339(21)71639 71688 (01)00884838055339(21)71688 71759 (01)00884838055339(21)71759 71681 (01)00884838055339(21)71681 71758 (01)00884838055339(21)71758 71863 (01)00884838055339(21)71863 71892 (01)00884838055339(21)71892 71926 (01)00884838055339(21)71926 85145 (01)00884838055339(21)85145 85057 (01)00884838055339(21)85057 85245 (01)00884838055339(21)85245 85246 (01)00884838055339(21)85246 71086 N/A 71343 N/A 71679 (01)00884838055339(21)71679 71671 (01)00884838055339(21)71671 71001 N/A 71014 N/A 71004 N/A 71002 N/A 71007 N/A 71039 N/A 71012 N/A 71013 N/A 71056 N/A 71035 N/A 71037 N/A 71070 N/A 71089 N/A 71154 N/A 71095 N/A 71093 N/A 71174 N/A 71175 N/A 71155 N/A 71183 N/A 71211 N/A 71210 N/A 71268 N/A 71269 N/A 71271 N/A 71282 N/A 71301 N/A 71325 N/A 71341 N/A 71347 N/A 71361 N/A 71385 N/A 71413 N/A 71416 N/A 71401 N/A 71411 N/A 71441 N/A 71450 N/A 71429 N/A 71425 N/A 71427 N/A 71438 N/A 71491 N/A 71489 N/A 71498 N/A 71500 N/A 71589 N/A 71463 N/A 71577 N/A 71562 N/A 71571 N/A 71558 N/A 71587 N/A 71527 (01)00884838055339(21)71527 71592 N/A 71673 (01)00884838055339(21)71673 71652 (01)00884838055339(21)71652 71682 (01)00884838055339(21)71682 71635 (01)00884838055339(21)71635 71670 (01)00884838055339(21)71670 71659 (01)00884838055339(21)71659 71655 (01)00884838055339(21)71655 71686 (01)00884838055339(21)71686 71684 (01)00884838055339(21)71684 71676 (01)00884838055339(21)71676 71772 (01)00884838055339(21)71772 71778 (01)00884838055339(21)71778 71801 (01)00884838055339(21)71801 71802 (01)00884838055339(21)71802 71766 (01)00884838055339(21)71766 71767 (01)00884838055339(21)71767 71780 (01)00884838055339(21)71780 71816 (01)00884838055339(21)71816 71760 (01)00884838055339(21)71760 71841 (01)00884838055339(21)71841 71849 (01)00884838055339(21)71849 71844 (01)00884838055339(21)71844 71882 (01)00884838055339(21)71882 71869 (01)00884838055339(21)71869 71851 (01)00884838055339(21)71851 71879 (01)00884838055339(21)71879 71878 (01)00884838055339(21)71878 71880 (01)00884838055339(21)71880 71694 (01)00884838055339(21)71694 71862 (01)00884838055339(21)71862 71850 (01)00884838055339(21)71850 71853 (01)00884838055339(21)71853 71897 (01)00884838055339(21)71897 71813 (01)00884838055339(21)71813 71885 (01)00884838055339(21)71885 71825 (01)00884838055339(21)71825 71864 (01)00884838055339(21)71864 71881 (01)00884838055339(21)71881 71921 (01)00884838055339(21)71921 71923 (01)00884838055339(21)71923 71972 (01)00884838055339(21)71972 71995 (01)00884838055339(21)71995 71992 (01)00884838055339(21)71992 85076 N/A 85064 (01)00884838055339(21)85064 85022 (01)00884838055339(21)85022 85074 (01)00884838055339(21)85074 85078 (01)00884838055339(21)85078 85038 (01)00884838055339(21)85038 85083 (01)00884838055339(21)85083 85068 (01)00884838055339(21)85068 85069 (01)00884838055339(21)85069 85124 (01)00884838055339(21)85124 85151 (01)00884838055339(21)85151 85121 (01)00884838055339(21)85121 85150 (01)00884838055339(21)85150 85217 (01)00884838055339(21)85217 85381 (01)00884838055339(21)85381 85400 (01)00884838055339(21)85400 71228 N/A 71107 N/A 85126 (01)00884838055339(21)85126 85166 (01)00884838055339(21)85166 71058 N/A 71078 N/A 71088 N/A 71176 N/A 71263 N/A 71299 N/A 71303 N/A 71321 N/A 71387 N/A 71307 N/A 71420 N/A 71475 N/A 71574 N/A 71640 N/A 71575 (01)00884838055339(21)71575 71658 (01)00884838055339(21)71658 71697 (01)00884838055339(21)71697 71625 (01)00884838055339(21)71625 71740 (01)00884838055339(21)71740 71757 (01)00884838055339(21)71757 71852 (01)00884838055339(21)71852 71984 (01)00884838055339(21)71984 85032 (01)00884838055339(21)85032 85102 (01)00884838055339(21)85102 85187 (01)00884838055339(21)85187 85181 (01)00884838055339(21)85181 85312 (01)00884838055339(21)85312 85330 (01)00884838055339(21)85330 71811 (01)00884838055339(21)71811 71172 N/A 71195 N/A 71790 (01)00884838055339(21)71790 71996 (01)00884838055339(21)71996 85004 (01)00884838055339(21)85004 71948 (01)00884838055339(21)71948 85046 (01)00884838055339(21)85046 85136 (01)00884838055339(21)85136 85223 (01)00884838055339(21)85223 85317 (01)00884838055339(21)85317 71600 N/A 71848 (01)00884838055339(21)71848 85109 (01)00884838055339(21)85109 85253 (01)00884838055339(21)85253 85301 (01)00884838055339(21)85301 71170 N/A 71153 N/A 71296 N/A 71356 N/A 71781 (01)00884838055339(21)71781 85213 (01)00884838055339(21)85213 71159 N/A 85021 (01)00884838055339(21)85021 71364 N/A 71380 N/A 71563 N/A 71953 (01)00884838055339(21)71953 71956 (01)00884838055339(21)71956 85232 (01)00884838055339(21)85232 85304 (01)00884838055339(21)85304 71166 N/A 71279 N/A 71290 N/A 71335 N/A 71375 N/A 71297 N/A 71608 N/A 71630 (01)00884838055339(21)71630 71715 N/A 71889 (01)00884838055339(21)71889 71919 N/A 85148 (01)00884838055339(21)85148 85367 (01)00884838055339(21)85367 71060 N/A 71611 (01)00884838055339(21)71611 71208 N/A 71097 N/A 71722 (01)00884838055339(21)71722 71026 N/A 71157 N/A 71381 N/A 71374 N/A 71647 N/A 71302 N/A 85366 (01)00884838055339(21)85366 71150 N/A 71188 N/A 71188 N/A 71360 N/A 71634 N/A 71665 (01)00884838055339(21)71665 71884 (01)00884838055339(21)71884 71225 N/A 71262 N/A 71348 N/A 71641 N/A 71510 (01)00884838055339(21)71510 71746 (01)00884838055339(21)71746 71753 (01)00884838055339(21)71753 85018 (01)00884838055339(21)85018 71648 N/A 71414 N/A 85236 (01)00884838055339(21)85236 85260 (01)00884838055339(21)85260 85368 (01)00884838055339(21)85368 85091 (01)00884838055339(21)85091 71220 N/A 71227 N/A 71350 N/A 71272 N/A 71451 N/A 71700 (01)00884838055339(21)71700 71522 (01)00884838055339(21)71522 71920 (01)00884838055339(21)71920 85012 (01)00884838055339(21)85012 85054 (01)00884838055339(21)85054 85316 (01)00884838055339(21)85316 85388 (01)00884838055339(21)85388 85414 (01)00884838055339(21)85414 71077 N/A 71365 N/A 71398 N/A 71204 N/A 71340 N/A 71305 N/A 71362 N/A 71445 N/A 71446 N/A 71508 N/A 71565 (01)00884838055339(21)71565 71564 (01)00884838055339(21)71564 71616 (01)00884838055339(21)71616 71615 (01)00884838055339(21)71615 71566 (01)00884838055339(21)71566 71925 (01)00884838055339(21)71925 71478 N/A 71618 N/A 71826 (01)00884838055339(21)71826 71669 (01)00884838055339(21)71669 71764 (01)00884838055339(21)71764 71833 (01)00884838055339(21)71833 71867 (01)00884838055339(21)71867 71017 N/A 71274 N/A 71291 N/A 71304 N/A 71368 N/A 71371 N/A 71484 N/A 71711 (01)00884838055339(21)71711 71756 (01)00884838055339(21)71756 71822 (01)00884838055339(21)71822 71860 (01)00884838055339(21)71860 71911 (01)00884838055339(21)71911 71936 (01)00884838055339(21)71936 71931 (01)00884838055339(21)71931 85125 (01)00884838055339(21)85125 85185 (01)00884838055339(21)85185 85123 (01)00884838055339(21)85123 85193 (01)00884838055339(21)85193 71333 N/A 71377 N/A 71386 N/A 71524 N/A 71789 (01)00884838055339(21)71789 71785 (01)00884838055339(21)71785 71986 (01)00884838055339(21)71986 85019 (01)00884838055339(21)85019 85209 (01)00884838055339(21)85209 85295 (01)00884838055339(21)85295 85322 (01)00884838055339(21)85322 71156 N/A 71314 N/A 71344 N/A 71323 N/A 71583 N/A 71808 (01)00884838055339(21)71808 71916 N/A 71038 N/A 71010 N/A 71027 N/A 71062 N/A 71029 N/A 71031 N/A 71022 N/A 71071 N/A 71016 N/A 71065 N/A 71073 N/A 71045 N/A 71064 N/A 71074 N/A 71185 N/A 71187 N/A 71194 N/A 71191 N/A 71193 N/A 71203 N/A 71200 N/A 71190 N/A 71213 N/A 71275 N/A 71319 N/A 71322 N/A 71277 N/A 71312 N/A 71329 N/A 71327 N/A 71331 N/A 71317 N/A 71336 N/A 71286 N/A 71378 N/A 71346 N/A 71358 N/A 71379 N/A 71376 N/A 71355 N/A 71388 N/A 71382 N/A 71444 N/A 71407 N/A 71449 N/A 71369 N/A 71495 N/A 71415 N/A 71483 N/A 71399 N/A 71532 N/A 71528 N/A 71529 N/A 71556 N/A 71569 N/A 71456 N/A 71513 N/A 71397 N/A 71570 N/A 71599 (01)00884838055339(21)71599 71584 N/A 71667 (01)00884838055339(21)71667 71675 (01)00884838055339(21)71675 71646 (01)00884838055339(21)71646 71739 (01)00884838055339(21)71739 71732 (01)00884838055339(21)71732 71721 (01)00884838055339(21)71721 71680 (01)00884838055339(21)71680 71683 (01)00884838055339(21)71683 71796 (01)00884838055339(21)71796 71805 (01)00884838055339(21)71805 71827 (01)00884838055339(21)71827 71810 (01)00884838055339(21)71810 71735 (01)00884838055339(21)71735 71836 (01)00884838055339(21)71836 71828 (01)00884838055339(21)71828 71858 (01)00884838055339(21)71858 71893 (01)00884838055339(21)71893 71750 (01)00884838055339(21)71750 71914 (01)00884838055339(21)71914 71829 (01)00884838055339(21)71829 71959 (01)00884838055339(21)71959 71907 (01)00884838055339(21)71907 71960 (01)00884838055339(21)71960 71982 (01)00884838055339(21)71982 85006 (01)00884838055339(21)85006 71971 (01)00884838055339(21)71971 85067 (01)00884838055339(21)85067 85094 (01)00884838055339(21)85094 85066 (01)00884838055339(21)85066 85154 (01)00884838055339(21)85154 85191 (01)00884838055339(21)85191 85221 (01)00884838055339(21)85221 85201 (01)00884838055339(21)85201 85279 (01)00884838055339(21)85279 85278 (01)00884838055339(21)85278 85275 (01)00884838055339(21)85275 85394 (01)00884838055339(21)85394 71436 N/A 85222 (01)00884838055339(21)85222 71161 N/A 71270 N/A Model: 781377 UDI N/A 42204 42190 42175 42154 42186 42246 42346 42354 42088 42153 42125 42026 42221 42231 42224 42291 42283 42167 42339 42319 42393 42387 42439 42441 42466 42002 42171 42147 42277 42305 42243 42198 42183 42182 42206 42213 42448 42215 42012 42009 42007 42011 42008 42010 42085 42079 42065 42164 42134 42165 42037 42132 42320 42176 42318 42230 42303 42350 42388 42332 42351 42399 42338 42419 42251 42326 42343 42362 42367 36 42380 42398 42436 42435 42444 42423 42446 42445 42453 42458 42459 42452 42454 42456 42463 42464 42437 42457 42469 42499 42490 42494 42492 42500 42495 42507 42496 42504 42508 42506 42510 42525 42528 42503 42547 42512 42548 42543 42522 42530 42556 42505 42545 42546 42549 42554 42555 42558 42553 42560 42502 42557 42491 42559 42561 42565 42552 42563 42520 42570 42531 42280 42493 42042 42239 42005 42013 42021 42030 42025 42073 42028 42027 42061 42029 42107 42081 42144 42145 42138 42130 42141 42202 42090 42082 42216 42143 42308 42292 42279 42363 42315 42369 42329 42313 42384 42178 42211 42321 42041 42197 42015 42092 42232 42265 42055 42114 42044 42220 42223 42358 42413 42323 42089 42086 42272 42136 42137 42072 42110 42191 42192 42195 42184 42225 42218 42285 42364 42407 42440 42426 42172 42284 42199 42275 42287 42062 42122 42014 42023 42048 42024 42047 42056 42075 42103 42054 42077 42070 42094 42124 42095 42128 42121 42093 42074 42162 42133 42078 42161 42179 42205 42112 42219 42203 42233 42222 42210 42249 42253 42261 42194 42257 42278 42288 42237 42245 42262 42276 42263 42314 42115 42260 42282 42252 42254 42289 42331 42309 42301 42345 42250 42299 42337 42333 42347 42361 42375 42392 42378 42404 42381 42385 42300 42330 42396 42349 42383 42425 42412 42409 42424 42421 42432 42422 42420 42442 42360 42428 42087 42120 42170 42201 42267 42386 42401 42415 42449 42450 42069 42294 42390 42451 42017 42228 42209 42151 42135 42271 42408 42217 42148 42402 42234 42235 42236 42353 42244 42455 42018 42105 42306 42256 42340 42355 42113 42097 42058 42264 42131 42348 42273 42001 42003 42006 42019 42040 42034 42033 42038 42036 42046 42031 42053 42032 42068 42052 42049 42100 42035 42104 42116 42045 42076 42096 42050 42102 42123 42152 42083 42109 42067 42101 42146 42117 42059 42111 42173 42163 42119 42099 42126 42127 42177 42180 42159 42160 42158 42150 42185 42189 42066 42187 42169 42214 42229 42057 42242 42098 42247 42248 42196 42193 42238 42266 42241 42240 42274 42258 42286 42334 42328 42293 42298 42356 42342 42307 42322 42370 42368 42366 42376 42352 42389 42365 42403 42416 42429 42414 42043 42359 42438
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 964 units, 422 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 Medical Systems Nederland B.V.
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