| |
Class 2 Device Recall Philips |
 |
| Date Initiated by Firm |
November 12, 2021 |
| Create Date |
December 09, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0356-2022 |
| Recall Event ID |
89129 |
| 510(K)Number |
K010435
|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product |
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system.
Model Number: 718095
|
| Code Information |
serial Numbers:
2368
257
252
1234
1139
1989
12662
604
1858
4196
2046
1826
312
313
1360
2438
802
844
1620
3007
2348
318
303
2737
2739
1197
2564
983
236
481
1983
386
13027
74
75
589
693
154
2735
13242
377
798
4466
687
77
565
1101
112
2836
2837
1703
13006
13014
2427
12954
1982
4740
13796
13795
561
13823
13824
597
671
1089
113
1732
13156
1866
2423
1427
325
108
3721
3189
326
3093
603
622
924
282
1984
1152
3009
1059
1136
981
2342
2666
196
73
1650
793
794
799
800
444
3857
289
2866
2020
1138
1547
1548
2708
13604
415
548
3186
2409
2760
3485
3487
2012
48
1869
50
927
193
351
383
384
2811
2821
1885
12566
1937
2365
2810
3078
12618
12619
12620
12621
12622
12623
12624
12625
12626
12628
4080
13051
3534
3301
2279
2385
194
609
52
2185
2311
2366
2177
1461
488
489
492
13519
3568
4758
4759
130
398
3760
2978
3594
1609
1709
2284
4475
285
4390
740
485
2430
38
635
1938
117
13810
3513
13
951
13456
12495
1140
2095
639
1990
2300
1448
897
577
1820
378
259
4381
1744
1745
1746
3512
505
2707
2888
2706
40
1575
2644
2281
1378
2807
1376
12692
1956
535
12895
1148
1987
570
641
366
1438
2526
177
15
2397
1986
3516
2606
644
1734
1735
381
3103
102
514
1085
2003
13402
30
278
1030
1831
139
1586
1567
431
1478
402
806
3058
3962
3963
2266
2227
13326
4022
1487
2338
4094
306
4380
1608
152
12678
3079
591
13394
35
2411
550
2915
1818
121
2704
13072
1048
4320
1677
4137
103
104
111
3190
987
988
2679
64
2410
182
227
2216
92
484
475
1660
1291
58
2465
2843
82
424
2111
13634
2126
1463
2194
2897
2898
2899
2900
2901
1981
1474
2424
1488
1736
1537
2075
3005
437
1797
2819
2437
2822
2431
3632
13312
3495
655
719
33
54
304
307
309
12651
652
879
933
1509
1079
1741
1742
1726
1727
3527
1037
2436
2926
2927
12778
893
2336
886
2282
810
1417
1201
1558
2444
2485
744
273
1049
1424
2667
2668
2169
68
3195
645
62
545
12744
219
2280
766
13381
69
70
623
657
1185
3451
619
1055
213
792
590
12529
12706
684
1470
389
551
1783
3273
3274
1018
3128
564
242
243
938
504
513
1067
3199
411
61
352
12966
1455
926
2025
2617
4077
4772
263
264
265
266
267
268
269
270
271
272
441
3761
56
739
2473
3381
694
809
625
324
1038
13714
13717
2736
1497
867
12701
76
13214
12579
901
1161
2418
2525
612
1361
1363
2448
677
479
405
818
4778
1968
2570
2575
12548
42
1606
1607
1967
2341
3519
3520
3557
4742
4757
2016
669
3469
1221
293
3514
292
471
287
1647
1574
1026
1027
1028
109
2571
2572
365
1743
12707
1529
2203
3539
1340
2120
2121
1135
12474
13398
13116
1657
1091
3442
13071
1192
2559
2786
508
1471
1634
539
4470
291
1147
13581
12642
470
32
211
89
90
2432
895
2441
1506
200
1131
1476
13112
12429
971
2527
12567
12859
13007
2118
2119
2565
2860
986
1663
782
2022
3213
3196
72
418
2168
1865
3086
795
2183
2064
1496
1102
796
797
1422
3209
4090
4091
4092
1472
3730
2561
2931
1256
2440
1648
1483
2566
244
245
246
875
235
13062
2562
1029
541
256
1259
1615
1872
2358
2834
115
3101
3090
4615
464
465
990
804
349
1477
1479
201
238
41
1416
3504
1966
825
878
2916
2611
1946
1597
2097
3238
2135
1848
480
1546
3191
3731
12702
13636
12987
447
2635
2636
100
191
1041
1132
2187
159
741
923
977
4391
826
1527
2832
3517
374
3370
3375
1480
3327
4613
4614
223
44
3411
3092
1991
13243
2923
221
12953
440
31
691
726
392
2919
529
1536
26
718
13307
2689
4103
3515
824
391
1898
582
820
1903
210
116
747
887
1033
1065
646
49
3855
1523
1999
1998
4373
2000
991
1250
2744
1356
2246
4423
4424
1731
2455
91
379
320
311
2277
3319
12801
2477
251
1130
1988
1588
1589
1590
616
1572
209
640
99
34
39
801
3968
1635
1979
43
2863
654
13829
66
3664
1827
2429
3184
414
605
663
664
665
413
662
13505
647
1429
769
2484
542
543
4227
1323
1970
357
358
3210
2865
1965
1220
416
1992
1475
408
1857
348
982
1819
319
2958
3134
12501
2099
3392
37
12900
178
3069
1032
1305
1894
403
1141
1142
3076
4751
4756
3109
1530
1868
1423
4569
13209
2818
12603
4727
4728
4729
4730
2702
4078
1980
928
929
930
931
932
2703
12975
1362
2349
2350
902
3088
1528
249
2612
487
1058
13665
13628
2820
1921
827
686
2042
1226
1306
1659
1661
3856
626
627
2766
2767
660
29
12969
12790
13549
2844
3424
13462
1364
2993
2994
65
2823
2043
1390
2713
2714
13751
852
853
13476
1070
3986
2548
816
137
410
859
2867
1016
1656
2110
2435
2917
13257
13258
284
218
2204
2231
1682
1900
1193
746
87
2541
3486
247
248
624
1108
350
169
610
474
355
356
894
295
300
220
2128
67
1712
2259
3944
150
898
717
860
1017
2959
4345
190
1377
2618
2425
659
138
1156
13203
13477
1298
1258
2094
168
167
317
1662
217
12681
2443
1936
2573
3102
195
134
135
682
2759
3892
3121
1203
3398
1758
13707
1784
12454
515
2271
250
721
478
57
2747
1425
750
2588
621
934
1066
1605
1658
2186
3187
3237
3239
12923
12924
985
1603
4239
4240
13212
12463
3418
4528
4529
3744
4264
126
3087
892
1307
668
3802
2439
4616
12922
13779
13026
13029
13496
13025
2549
13538
13539
3573
13028
733
12650
1685
1959
3584
3661
3663
4706
12466
13032
13498
3662
13030
13033
690
2722
1681
1526
3091
13530
141
142
143
148
149
1598
1599
1600
1601
12904
706
12766
705
707
688
1420
1421
2491
2557
2558
2560
2005
2018
521
4212
4213
12990
12991
1654
1655
2225
2226
2670
1260
2041
614
321
2044
1922
2127
1251
128
180
2428
2433
704
2469
4770
658
728
2421
2426
12690
1129
1447
1931
421
1145
1616
576
1240
4114
1482
395
534
562
3540
3619
533
544
634
1498
2614
1133
60
1919
670
13038
2434
1308
1359
12634
2442
2486
2021
2738
260
1198
13344
482
12
2716
3476
2247
222
1186
643
2563
1481
390
407
13742
1510
2130
1485
2528
224
1649
2253
1713
1462
120
2047
11
388
12522
3242
17
327
642
903
692
745
498
2711
1430
3089
472
427
425
3711
228
720
429
2073
2074
2924
207
78
114
3240
286
1187
950
13353
277
322
1679
3943
12647
129
428
1383
1531
140
854
3297
758
208
620
922
93
155
290
2918
240
1568
3293
3294
2697
791
1710
1908
783
784
2943
2178
1418
1419
1711
179
689
151
153
342
458
UDI:
As-Maintained System Unique Device Identifier (UDI#)
(01)00884838055506(21)2368
(01)00884838055506(21)257
(01)00884838055506(21)252
(01)00884838055506(21)1234
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(01)00884838055506(21)1989
(01)00884838055506(21)12662
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(01)00884838055506(21)983
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(01)00884838055506(21)1703
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(01)00884838055506(21)597
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(01)00884838055506(21)2012
(01)00884838055506(21)48
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(01)00884838055506(21)927
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(01)00884838055506(21)2811
(01)00884838055506(21)2821
(01)00884838055506(21)1885
(01)00884838055506(21)12566
(01)00884838055506(21)1937
(01)00884838055506(21)2365
(01)00884838055506(21)2810
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(01)00884838055506(21)130
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(01)00884838055506(21)3513
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(01)00884838055506(21)13456
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(01)00884838055506(21)639
(01)00884838055506(21)1990
(01)00884838055506(21)2300
(01)00884838055506(21)1448
(01)00884838055506(21)897
(01)00884838055506(21)577
(01)00884838055506(21)1820
(01)00884838055506(21)378
(01)00884838055506(21)259
(01)00884838055506(21)4381
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(01)00884838055506(21)1746
(01)00884838055506(21)3512
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(01)00884838055506(21)40
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(01)00884838055506(21)1987
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(01)00884838055506(21)1986
(01)00884838055506(21)3516
(01)00884838055506(21)2606
(01)00884838055506(21)644
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|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall |
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
|
FDA Determined
Cause 2 |
Device Design |
| Action |
Philips issued an Urgent Medical Device Correction letter in the USA on 11/12/21 via Certified mailing United States Postal Service. Recalling outside the US is done through the local Philips organizations in the respective countries
Letter states reason for recall, health risk and action to take:
Pay attention to the Heat Indication Level Icons shown in the Viewing Station to know the temperature of the X-Ray Tank.
o Follow the instructions provided in Annex I of this letter for a safe use of the system.
o Circulate this notice to all users of this device so that they are aware of the issue.
o Place this Field safety Notice with the documentation of the of your system
o Transfer this Field Safety notice within your organization or to any organization, if the affected devices have been transferred.
o Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this Urgent Field Safety Notice.
5. Actions planned by Philips IGT Systems to correct the problem
Philips is informing customers through this Urgent Field Safety Notice and providing the Addendum to the Instructions For Use of the BV Endura Release 2.3, BV Pulsera Release 2.3 and Veradius Unity Release 2.1 systems.
|
| Quantity in Commerce |
1201 units |
| Distribution |
Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan,
Kazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic,
Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives
Mali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar,
Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan,
Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal,
Puerto Rico, Qatar, R¿union Romania, Russian Federation, Rwanda, Saudi Arabia,
Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan,
Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan,
Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela,
Viet Nam, Yemen, Zambia, Zimbabwe.
|
| 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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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