|
Class 2 Device Recall Allura Xper FD series and Allura Xper OR Table series |
|
Date Initiated by Firm |
January 02, 2024 |
Date Posted |
February 16, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1156-2024 |
Recall Event ID |
93777 |
510(K)Number |
K162859 K130638 K130842 K133292 K141979 K161563
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems.
Allura Xper Model Name - Model Number:
Allura Xper FD10 722003 722010 722026;
Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058;
Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
(Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.) |
Code Information |
Allura Xper FD10
722003 - no UDI
Serial Numbers
105
1181
1209
1349
1435
1472
1529
1555
1594
1700
1719
1788
285
472
482
912
913
928
,
722010 - UDI-DI 00884838059030 or 00884838059191
Serial Numbers
1005
1009
1011
1025
1028
1040
1041
1042
1043
1048
1064
1069
107
1078
1082
1084
1108
1109
1112
1118
1123
1126
1128
1132
1144
1149
1170
1173
1176
1181
1183
1209
1210
1214
1226
1230
1233
1234
1235
1236
1244
1261
1263
1275
1279
1283
1287
1292
1297
1298
1302
1308
1309
1310
1312
1328
133
1336
1344
1347
1369
1370
1373
1391
1395
1396
1397
1398
1424
1436
1440
1442
145
170
177
191
209
214
252
314
33
337
343
344
39
414
43
467
468
477
480
500
527
572
585
604
609
61
611
624
646
65
651
656
662
667
668
670
679
68
714
728
754
755
763
767
791
794
809
818
830
838
839
873
882
896
902
905
914
917
920
921
931
932
937
939
946
965
968
970
976
979
986
987
992
999
,
722026 - UDI-DI 00884838054189
Serial Numbers
100
101
102
1050
1052
1068
109
11
110
112
114
115
116
117
1205
121
1210
122
130
142
151
155
156
185
190
191
192
204
215
220
221
223
233
234
244
245
253
258
259
265
284
297
319
323
324
335
344
368
370
374
378
381
391
394
396
400
431
432
436
444
458
462
465
484
485
512
522
531
543
544
558
559
560
561
562
563
600
601
602
604
605
612
614
617
618
622
627
633
634
646
648
653
663
664
683
713
716
725
73
731
738
74
75
765
774
78
781
786
79
796
805
826
832
841
845
87
877
878
908
93
931
959
965
966
967
98
985
99
;
Allura Xper FD10/10
722005 - no UDI
Serial Numbers
261
329
344
456
49
523
63
,
722011 - no UDI
Serial Numbers
101
102
103
107
123
124
132
133
140
15
157
163
168
169
170
171
172
173
23
234
237
255
267
268
269
270
275
279
308
319
324
325
33
332
344
345
358
362
375
380
57
58
59
76
82
83
84
87
,
722027 - UDI-DI 00884838054196 or 00884838059191
Serial Numbers
1
106
107
112
116
120
123
127
133
134
152
153
156
164
169
174
175
178
179
183
202
203
209
216
222
230
240
241
246
255
263
265
266
284
29
305
306
319
32
332
342
39
40
41
42
43
49
50
56
71
;
Allura Xper FD10C
722001 - no UDI
Serial Numbers
213
273
;
Allura Xper FD20
722006 - UDI-DI 00884838059115
Serial Numbers
1007
1132
1210
1221
1276
1420
1439
1444
1446
1461
1469
1476
1507
1588
1589
1659
1661
1705
1720
1812
1830
1848
1870
1875
1913
1922
1942
1955
2008
2126
2147
2199
2203
2323
2404
2425
45
468
518
559
638
673
675
683
722
723
774
804
806
810
886
904
,
722012 - UDI-DI 00884838059054, 00884838059191, or 00884838059207
Serial Numbers
100
1002
1003
1005
101
1017
1020
1023
1027
103
1032
1033
1034
1036
1037
1038
1045
1047
1054
1058
1062
1083
1091
1092
1098
1099
1100
1102
1104
1105
1113
1115
1116
1117
1119
114
1141
1148
1167
1189
1192
1195
1207
1210
1211
1212
1216
1219
1226
1239
1240
1249
1250
1254
126
1265
1269
1270
1271
1272
1279
1282
1285
1286
1293
1294
1305
1316
1317
1321
1324
1328
1334
1335
1337
1344
1345
1354
1357
1359
1396
1399
1404
1405
1406
1407
1408
141
1422
1426
1440
1441
1442
1446
1447
1455
1456
1461
1467
1473
1477
1478
1497
1506
1507
1508
1512
1513
1515
1516
1527
1531
1532
1533
1537
1538
1542
1545
1549
1550
1558
1559
1560
1561
1570
1581
1586
1587
1588
1589
1590
1593
1594
1595
1596
1597
1598
1599
1606
1607
1608
1610
1611
1613
1616
1617
1622
1625
1630
1635
1641
1645
1649
1652
1656
1657
1658
1659
1660
1661
1662
1664
1665
1672
1673
1675
1683
1686
1688
1690
1692
1712
1713
1714
1715
1716
1723
1724
1726
1731
1732
1733
1734
1735
174
1743
1746
1792
1793
1796
1797
1798
1799
1803
1804
1805
1806
1807
1809
1811
1823
1827
1832
1842
1848
1852
1854
1858
1868
1869
1871
1889
1894
1895
1900
1904
1906
1908
1916
1918
1919
1922
1923
1924
1941
1943
1945
1946
1947
1948
1950
1953
196
1960
1961
1964
197
1975
1989
1990
1992
1993
2002
2003
2004
2006
2013
2014
2015
2022
2046
2054
2057
2063
2064
2065
2068
2081
2085
2086
2092
2133
2134
2135
2136
2138
2145
2146
2148
2149
2150
2151
2161
2166
2171
2201
2202
2203
2207
2215
2219
2221
2222
2227
2234
224
2254
2264
2265
2269
2276
2283
2285
2286
2288
2289
2292
2293
2302
2303
2305
2307
2308
2309
231
2310
2311
2313
2319
2323
233
2353
2454
248
2484
2508
2509
2511
2512
2514
2515
2516
2518
2521
2522
2607
2609
2610
2614
2629
2645
2653
2655
2656
2657
2658
2677
2687
2692
2693
2696
2697
2707
2712
2713
2721
2722
2723
2726
2735
2736
274
2740
2742
2755
2760
277
2821
2828
2829
2835
2840
2841
2842
2843
2844
2849
2868
2869
2873
2875
2876
2881
2892
2898
2900
2912
2920
2925
2926
2929
2930
2937
2938
2943
310
314
316
320
322
323
326
336
337
348
352
383
386
394
406
412
424
430
435
440
442
444
445
447
448
450
452
453
456
470
474
476
484
489
498
505
511
51251061
513
518
520
527
531
533
560
570
577
580
583
585
589
590
596
597
601
606
613
633
642
643
644
649
650
656
66
666
669
67
671
675
676
68
685
689
691
694
695
718
731
733
735
756
757
760
766
768
787
788
790
791
792
828
84
846
848
851
852
86
865
88
888
893
894
92
920
923
924
93
935
939
95
950
952
953
954
959
963
964
974
975
976
986
99
990
D902-214-00
,
722028 - UDI-DI 00884838054202, 00884838059191, or 00884838059269
Serial Numbers
1
1000
1001
1002
1004
1014
1017
1022
1030
1032
1034
1041
1043
1050
1051
1054
1068
1074
1076
1077
1081
1094
1095
1098
1099
11
110
1100
1103
1111
1116
1129
1130
1132
1136
1142
1154
1155
1156
1168
1171
1188
1189
1191
1200
1202
121
1211
1212
1213
1214
122
1222
1232
1233
125
1256
1261
1264
1267
1269
127
1275
1279
128
1288
129
130
131
132
133
1331
1333
1343
1350
1351
1352
1359
136
1368
137
1370
138
1387
139
1393
1394
1395
140
1407
1408
141
142
143
1446
145
1454
1457
1461
1482
1483
1484
1498
1508
151
1538
154
155
1556
1567
1568
158
159
160
161
1634
1650
1656
166
167
169
1710
172
173
1736
1755
176
1774
1783
180
1820
1824
184
1845
185
1875
189
190
1909
194
1949
195
197
204
205
206
207
208
209
211
213
215
216
217
218
222
224
227
228
229
234
236
237
238
242
251
256
257
260
261
262
265
267
272
273
274
2745
275
2760
279
280
281
282
283
284
289
292
2922
303
305
306
31
313
315
316
317
324
326
329
333
336
340
346
347
350
356
363
365
368
371
372
373
375
377
379
382
386
394
406
407
408
416
419
422
426
428
431
435
437
447
452
453
454
456
459
462
464
468
473
475
476
479
48
485
488
489
490
491
493
494
496
498
499
516
518
519
52
520
525
526
528
529
530
531
533
534
535
538
539
540
541
543
547
548
549
550
552
553
556
558
559
560
561
564
565
570
571
579
580
582
586
590
591
592
596
601
618
620
625
627
630
631
632
634
636
637
638
647
655
66
664
666
668
669
67
671
672
674
675
677
678
680
684
691
692
695
696
697
698
71
710
717
720
721
729
731
734
741
743
744
751
757
759
768
779
781
784
785
793
80
805
808
809
811
818
819
821
825
840
842
854
861
864
866
867
869
874
877
879
880
882
887
888
889
891
892
893
895
896
900
901
903
904
906
908
909
910
911
914
917
918
922
925
928
929
930
932
934
938
940
945
946
949
952
956
961
966
967
968
971
976
977
978
981
982
983
987
990
994
998
;
Allura Xper FD20 Biplane
722008 - no UDI
Serial Numbers
19
197
231
246
264
288
306
312
319
378
419
420
453
465
487
516
521
,
722013 - UDI-DI 00884838059061 or 00884838080805
Serial Numbers
100
105
106
113
115
124
125
126
129
140
147
148
149
150
151
152
153
159
164
174
175
178
179
203
205
214
218
228
241
244
253
254
262
264
266
269
274
278
289
290
297
30
303
304
307
308
309
313
316
327
330
342
35
357
360
377
379
383
389
392
401
402
404
410
42
422
424
426
427
428
43
435
441
442
45
46
461
462
467
475
479
480
481
491
492
495
496
497
500
505
507
511
513
515
518
519
531
550
556
561
562
564
573
575
580
599
601
603
626
631
634
637
639
69
84
96
;
Allura Xper FD20 Biplane OR Table
722025 - no UDI
Serial Numbers
2
3
;
Allura Xper FD20 OR Table
722023 - UDI-DI 00884838059085
Serial Numbers
109
110
113
116
117
118
124
127
128
138
142
147
160
175
179
18
35
41
46
66
71
72
75
82
98
,
722035 - UDI-DI 00884838054240
Serial Numbers
100
101
117
121
123
124
125
126
127
131
143
147
165
172
183
187
192
196
21
222
236
24
30
34
38
46
47
52
57
59
60
72
74
85
88
89
;
Allura Xper FD20/10
722029 - UDI-DI 00884838054219
Serial Numbers
110
129
21
22
30
31
55
56
57
60
62
63
7
71
84
88
94
97
;
Allura Xper FD20/15
722058 - UDI-DI 00884838059115 or 00884838059191
Serial Numbers
100
109
111
123
124
129
134
135
138
146
149
156
162
167
168
171
172
178
186
190
196
197
199
200
202
203
205
212
215
219
22
23
238
239
24
249
257
259
265
278
279
285
290
304
305
337
340
38
4
405
5
56
59
61
65
71
82
85
94
99
;
Allura Xper FD20/20
722038 - UDI-DI 00884838054226
Serial Numbers
106
115
118
119
120
131
137
141
157
173
35
37
38
39
41
42
46
48
49
55
60
62
63
67
7
70
71
78
96
;
Allura Xper FD20/20 OR Table
722039 - No UDI
Serial Number
3
; |
Recalling Firm/ Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
|
Manufacturer Reason for Recall |
Dual In-Line Memory Modules (DIMMs) 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 DIMMs 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 |
5,500 (1,681 US; 3,819 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
|
|
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 B.V. 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
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