|
Class 2 Device Recall Azurion R2.1 |
|
Date Initiated by Firm |
January 02, 2024 |
Date Posted |
February 16, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1152-2024 |
Recall Event ID |
93781 |
510(K)Number |
K200917 K172822
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system.
Affected PCs: XRay PC, Suite PC, and FlexViewing PC
Azurion Model Name - Model Number:
Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224; |
Code Information |
Azurion 3 M12
722063 - UDI-DI 00884838085275 or 00884838086777
Serial Numbers
108
122
131
132
56
64
84
96
98
,
722221 - UDI-DI 00884838099203
Serial Numbers
19
3
6
7
9
;
Azurion 3 M15
722064 - UDI-DI 00884838085282
Serial Numbers
201
209
218
229
238
258
259
260
261
267
270
291
314
335
64
,
722222 - UDI-DI 00884838099210
Serial Numbers
12
15
17
19
23
;
Azurion 5 M20
722228 - UDI-DI 00884838099234
Serial Numbers
10
17
18
23
24
25
26
29
38
49
62
;
Azurion 7 B12
722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350
Serial Numbers
103
104
109
114
115
123
131
132
133
141
147
148
150
163
172
173
190
192
208
214
221
225
234
244
250
26
277
278
36
41
42
46
57
69
70
71
75
81
92
98
,
722225 - UDI-DI 00884838099265
Serial Numbers
28
29
37
41
53
72
;
Azurion 7 B20
722068 - UDI-DI 00884838059207, 00884838064775, 00884838085367, or 00884838101883
Serial Numbers
101
103
104
107
109
110
111
113
114
117
130
136
137
143
146
147
149
150
153
170
172
178
184
196
205
213
225
232
239
243
247
251
261
262
270
271
277
279
282
285
288
295
304
308
319
320
322
323
324
329
330
335
337
350
354
356
361
370
373
374
400
406
407
413
418
42
431
440
442
443
446
457
462
467
469
470
472
477
479
487
490
494
505
510
511
520
524
528
547
564
64
73
75
76
78
82
84
85
89
95
,
722226 - UDI-DI 00884838099272 or 00884838101883
Serial Numbers
100
105
107
108
11
112
113
117
120
121
122
123
124
125
126
127
129
139
143
144
147
153
159
173
174
180
181
19
220
255
59
67
75
78
98
;
Azurion 7 M12
722078 - UDI-DI 00884838085251 or 00884838101890
Serial Numbers
1007
121
125
136
141
143
163
165
166
170
187
215
22
224
232
239
240
249
251
256
257
258
269
271
278
279
289
290
291
292
293
294
296
298
302
305
308
309
31
317
327
359
360
364
376
379
383
384
396
399
402
410
412
415
425
436
437
438
441
445
456
465
478
479
480
481
483
488
491
493
497
500
513
520
521
522
523
524
532
535
536
537
538
539
544
545
546
550
556
557
558
559
566
571
576
585
598
603
611
612
613
626
627
635
644
645
649
654
656
657
658
661
677
679
684
697
700
709
719
720
723
725
728
748
753
786
788
803
824
829
833
840
844
862
870
876
890
902
906
921
,
722223 - UDI-DI 00884838099241 or 00884838101890
Serial Numbers
104
105
124
126
127
130
131
161
171
177
180
186
187
188
189
196
198
29
36
37
44
47
52
67
69
77
85
87
96
97
;
Azurion 7 M20
722079 - UDI-DI 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838101883, or 00884838101890
Serial Numbers
1005
1006
1007
1010
1012
1013
1018
1021
1022
1023
1032
1033
1040
1041
1042
1043
1048
1049
1054
1059
1062
1063
1064
1078
1084
1086
1090
1096
1097
1098
1100
1102
1103
1107
1108
1117
1137
1142
1155
1156
1157
1163
1164
1170
1171
1179
1187
1189
1200
1201
1204
1211
1212
1213
1216
1219
1222
1226
1230
1231
1232
1235
1236
1237
1238
1242
1245
1246
1247
1250
1251
1252
1258
1267
1268
1270
1271
1274
1276
1282
1283
1285
1289
1290
1297
1309
1310
1311
1312
1316
1322
1323
1346
1352
1355
1358
1359
1360
1361
1363
1365
1369
1370
1378
1379
1380
1381
1382
1385
1386
1387
1391
1392
1393
1395
1399
1400
1401
1402
1408
1410
1411
1412
1414
1423
1424
1430
1431
1432
1436
18
19
212
213
216
222
227
228
229
239
241
246
247
250
251
255
262
263
266
267
268
272
273
274
275
281
29
290
296
297
298
299
30
314
318
32
320
325
326
327
33
334
335
34
342
343
344
345
35
350
351
353
354
355
356
357
358
359
360
361
366
374
375
387
393
394
396
40
401
402
403
407
408
41
412
413
414
415
416
417
420
422
423
424
427
428
429
43
436
437
438
439
445
447
448
45
453
455
459
46
460
465
466
468
469
47
470
471
472
474
479
48
480
481
483
488
496
497
499
50
51
52
520
525
526
528
53
534
535
536
537
54
540
543
55
56
564
57
572
573
574
577
58
580
581
584
585
587
588
590
593
594
595
598
599
60
602
605
607
608
611
613
617
618
62
621
628
629
631
633
634
637
64
645
646
65
653
654
655
658
663
668
669
671
673
674
68
684
689
691
697
70
702
703
703305
703306
703307
703308
703309
703310
703311
703314
703317
703323
703324
703327
703329
703332
703333
703334
703335
703336
703344
703345
703350
703360
703368
703379
703383
703387
703389
703390
703391
703395
703396
703402
703404
703407
703408
703409
703413
703416
703418
703419
703420
703425
703426
703435
703450
703455
703456
703457
703465
703478
703486
703493
703495
703497
703501
703508
703510
703515
703521
703528
703532
703540
703558
703559
703562
703575
703584
703615
703775
703861
706
708
709
710
711
713
714
715
716
717
721
730
731
736
737
738
741
742
746
747
751
753
754
755
758
766
769
774
776
777
78
790
792
793
795
797
800
801
802
804
805
809
810
813
817
818
820
828
836
837
838
840
841
842
843
847
848
854
856
857
858
859
860
862
863
865
866
867
868
877
878
879
881
883
884
885
887
888
890
891
895
896
897
898
899
900
903
904
905
908
909
910
911
912
915
919
921
922
923
925
927
928
930
931
937
938
939
940
942
944
945
946
948
954
955
957
959
974
981
987
989
990
991
992
998
999
,
722224 - UDI-DI 00884838059184, 00884838059191, 00884838059207, 00884838099258, or 00884838101883
Serial Numbers
100
1003
101
102
103
104
105
106
107
108
109
110
112
113
115
116
119
120
1235
124
1240
125
1278
128
129
130
131
134
139
140
141
147
148
151
153
154
159
160
163
164
165
166
174
176
177
178
182
183
1830
185
187
188
189
190
191
192
194
210
215
216
217
218
219
220
224
225
226
228
229
2308
232
233
234
235
238
239
240
244
246
250
251
252
253
254
260
261
262
265
266
267
268
271
272
273
275
277
278
279
28
285
286
287
288
289
291
295
298
301
306
307
308
312
326
327
329
33
331
332
333
335
339
34
342
343
346
350
36
360
362
363
364
366
369
370
373
374
381
385
39
391
395
40
400
404
409
41
414
42
425
43
433
435
436
441
45
452
453
46
461
466
47
472
482
49
490
50
503
512
526
53
554
56
564
587
592
622
64
715
72
735
75
76
763
78
79
80
82
84
88
90
91
94
99
; |
Recalling Firm/ Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
|
Manufacturer Reason for Recall |
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
|
FDA Determined Cause 2 |
Process design |
Action |
On January 2, 2024, the firm notified affected consignees via" URGENT Medical Device Correction" letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card.
This recall record is for the Disk Bay issue.
Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be corrected. Philips will be replacing the three components in all affected systems. Philips will contact customers to schedule a visit to replace the affected components. If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). |
Quantity in Commerce |
13, 133 (3,408 US; 9,725 ROW) |
Distribution |
Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, Iceland, 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, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, and Yemen. |
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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
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