| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | November 12, 2021 |
|---|
| Create Date | December 09, 2021 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0357-2022 |
|---|
| Recall Event ID |
89129 |
| 510(K)Number | K142708 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. .
Model Number: 718132 |
|---|
| Code Information |
Serial Numbers:
As-Maintained System Serial Number
1442
1517
1367
1088
1210
209
422
35
261
692
1468
1469
1470
1471
990
1447
578
579
318
103
1067
518
1022
1513
73
548
549
710
711
107
352
539
319
655
1512
2138
1643
1059
36
1058
1647
1201
884
835
836
1613
769
284
232
1253
1254
1255
427
428
429
618
1203
379
705
708
532
706
707
669
1583
1368
1369
88
84
126
971
218
1696
612
133
1770
458
496
1073
1324
982
1756
351
890
1199
1926
1540
1541
642
433
832
1916
776
664
1545
267
1955
1195
432
632
283
2044
1221
1222
187
188
190
919
1121
34
1491
1320
1187
945
540
1041
1440
1049
1050
1051
1052
1053
1614
425
437
1006
1007
1343
517
1497
80
113
257
303
304
305
306
307
2255
1310
668
673
1760
1797
1798
489
629
750
1060
1337
1338
2059
2094
2095
2104
1336
1335
1178
1692
1693
1694
1695
915
1394
974
975
976
977
613
1448
203
1261
611
1732
1737
375
1466
1467
944
1429
716
324
1963
651
972
702
1799
1869
1870
2063
2062
1134
888
519
33
591
610
1645
1683
1893
211
544
219
2121
411
430
641
643
645
652
928
175
174
256
159
806
328
240
620
1057
520
1188
1025
1027
1083
1103
682
987
1644
993
204
205
340
1675
1808
1809
76
77
568
1125
1126
659
1101
1451
1452
943
1120
1985
1136
179
180
181
182
183
184
464
889
1153
1154
1232
1649
1010
962
445
2036
1004
1516
75
1017
1395
1514
858
927
85
1133
462
523
1628
368
980
1008
1009
1054
584
1979
1980
1309
721
724
94
1319
1119
983
485
916
1342
431
901
1021
1026
722
715
1592
1593
254
286
1347
1578
424
136
137
2180
323
216
1747
89
1856
2099
587
592
1190
1860
2199
1861
1828
134
994
448
1615
833
859
396
337
1312
883
886
1068
1960
1311
237
925
926
936
1749
985
1949
1767
1768
657
1533
189
1928
751
871
872
873
874
1211
236
1911
385
386
924
1416
1534
1097
1098
831
1677
370
405
1558
1671
138
1641
718
719
720
68
58
67
69
71
72
903
350
426
2137
434
435
436
409
404
1733
1100
1684
1260
1262
573
1207
1198
736
1189
885
270
262
961
387
388
367
1314
1194
530
1612
215
986
521
378
1122
1868
1065
513
792
1127
74
569
127
128
129
130
402
704
777
1208
1209
654
272
1239
210
265
2208
666
674
277
1702
675
685
688
667
681
703
112
120
1413
1414
1096
1104
1105
671
672
371
515
UDI:
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(01)00884838058194(21)1194
(01)00884838058194(21)530
(01)00884838058194(21)1612
(01)00884838058194(21)215
(01)00884838058194(21)986
(01)00884838058194(21)521
(01)00884838058194(21)378
(01)00884838058194(21)1122
(01)00884838058194(21)1868
(01)00884838058194(21)1065
(01)00884838058194(21)513
(01)00884838058194(21)792
(01)00884838058194(21)1127
(01)00884838058194(21)74
(01)00884838058194(21)569
(01)00884838058194(21)127
(01)00884838058194(21)128
(01)00884838058194(21)129
(01)00884838058194(21)130
(01)00884838058194(21)402
(01)00884838058194(21)704
(01)00884838058194(21)777
(01)00884838058194(21)1208
(01)00884838058194(21)1209
(01)00884838058194(21)654
(01)00884838058194(21)272
(01)00884838058194(21)1239
(01)00884838058194(21)210
(01)00884838058194(21)265
(01)00884838058194(21)2208
(01)00884838058194(21)666
(01)00884838058194(21)674
(01)00884838058194(21)277
(01)00884838058194(21)1702
(01)00884838058194(21)675
(01)00884838058194(21)685
(01)00884838058194(21)688
(01)00884838058194(21)667
(01)00884838058194(21)681
(01)00884838058194(21)703
(01)00884838058194(21)112
(01)00884838058194(21)120
(01)00884838058194(21)1413
(01)00884838058194(21)1414
(01)00884838058194(21)1096
(01)00884838058194(21)1104
(01)00884838058194(21)1105
(01)00884838058194(21)671
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(01)00884838058194(21)371
(01)00884838058194(21)515
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| FEI Number |
3016618143
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Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
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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 |
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FDA Determined
Cause 2 | Device Design |
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| 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.
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| Quantity in Commerce | 462 units |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = OWB
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