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