| 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-1151-2024 |
Recall Event ID |
93781 |
510(K)Number | K031333 K130638 K141979 K161563 K162859 K163715 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: Imaging Processing PC, Host PC, FlexVision PC
Allura Xper Model Name - Model Number:
Allura Xper FD10
722003
722010
722026;
Allura Xper FD10 OR Table
722022;
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 FD20/15 OR Table
722059;
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
1031
105
1074
1114
1181
1187
1209
1311
1349
1435
1472
1529
1555
1594
1700
1719
1788
268
283
285
368
390
445
467
472
482
485
690
906
912
913
928
940
,
722010 - UDI-DI 00884838059030 or 00884838059191, some units do not have UDI
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
1365
1369
1370
1373
1391
1395
1396
1397
1398
1424
1425
1428
1432
1436
1440
1441
1442
145
158
170
175
177
190
191
209
214
215
218
227
241
244
252
280
281
285
286
290
314
327
33
337
343
344
359
360
365
38
39
40
414
42
422
423
43
453
467
468
477
478
479
480
485
488
500
505
521
527
531
567
572
585
592
604
605
609
61
611
624
636
637
638
641
646
648
65
651
656
662
667
668
670
671
673
675
677
679
68
683
690
693
694
698
714
728
730
754
755
763
764
767
780
784
785
787
788
791
792
794
809
818
821
826
830
833
838
839
873
878
882
890
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
1000
101
102
1038
1050
1051
1052
1068
1072
109
11
110
1100
1101
112
1126
1129
1132
114
115
116
117
1182
1189
1192
1205
121
1210
1215
122
1231
1239
1246
1248
1268
1287
1293
130
1338
1340
142
151
155
156
185
190
191
192
201
204
205
215
220
221
222
223
224
233
234
235
244
245
253
258
259
265
284
287
297
319
323
324
335
344
368
370
374
378
381
389
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
608
612
614
617
618
622
627
633
634
646
648
653
654
663
664
683
688
694
696
704
713
716
725
728
73
731
738
74
75
765
770
774
778
78
781
782
786
79
796
805
825
826
832
838
841
843
845
855
87
877
878
882
908
909
914
93
931
935
942
957
959
965
966
967
969
973
98
985
99
990
;
Allura Xper FD10 OR Table
722022 - No UDI
Serial Number 6
;
Allura Xper FD10/10
722005 - UDI-DI 00884838080805
Serial Numbers
212
259
261
270
329
343
344
392
399
449
456
474
480
49
523
63
,
722011 - no UDI
Serial Numbers
101
102
103
107
123
124
132
133
137
140
15
155
157
163
168
169
170
171
172
173
177
196
205
23
234
237
255
256
267
268
269
270
275
279
308
319
324
325
33
332
344
345
358
362
375
380
44
49
57
58
59
72
76
79
82
83
84
87
95
,
722027 - UDI-DI 00884838054196 or 00884838059191
Serial Numbers
1
104
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
231
234
240
241
246
255
263
265
266
267
280
284
288
29
298
305
306
307
319
32
332
335
342
351
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
1000
1007
1093
1104
1114
1127
1132
1174
120
1210
1221
1235
1259
1276
1318
1341
1364
1383
1387
1407
1420
1439
1444
1446
1461
1469
1476
1480
1507
1588
1589
1604
1610
1627
1648
1659
1661
1705
1720
1729
1752
1761
1772
1792
1807
1812
1827
1830
1845
1846
1848
1870
1872
1875
1888
1913
1921
1922
1942
1955
2002
2007
2008
2042
2058
2122
2126
2135
2140
2143
2147
2183
2195
2199
2200
2203
2268
2274
2283
2323
2404
2425
39
45
468
518
559
560
587
638
641
673
674
675
680
683
700
722
723
767
774
776
804
806
810
878
882
886
904
972
,
722012 - UDI-DI 00884838059054, 00884838059191, or 00884838059207
Serial Numbers
100
1001
1002
1003
1004
1005
101
1014
1016
1017
1019
1020
1022
1023
1026
1027
103
1032
1033
1034
1035
1036
1037
1038
104
1044
1045
1047
1053
1054
1058
1062
1063
1073
1075
1077
1078
1083
1084
1091
1092
1095
1096
1097
1098
1099
1100
1101
1102
1104
1105
1106
1108
1113
1115
1116
1117
1118
1119
1120
1126
1133
114
1140
1141
1148
1154
1166
1167
1177
1181
1187
1188
1189
1192
1195
1197
1207
1209
1210
1211
1212
1216
1217
1218
1219
1224
1226
123
1231
1238
1239
124
1240
1249
1250
1254
1255
126
1262
1265
1269
1270
1271
1272
1277
1279
1280
1281
1282
1285
1286
1293
1294
1301
1305
1306
1307
1316
1317
1321
1324
1326
1327
1328
1329
1334
1335
1336
1337
1344
1345
1354
1356
1357
1359
1396
1399
1401
1404
1405
1406
1407
1408
141
1422
1426
1430
1440
1441
1442
1446
1447
1455
1456
1461
1467
1473
1477
1478
1497
150
1506
1507
1508
1512
1513
1515
1516
1519
1527
1531
1532
1533
1537
1538
1542
1545
1549
1550
1558
1559
1560
1561
1570
1581
1583
1586
1587
1588
1589
1590
1593
1594
1595
1596
1597
1598
1599
1606
1607
1608
1610
1611
1613
1616
1617
1622
1625
1630
1635
1636
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
172
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
186
1868
1869
1871
1889
1894
1895
1900
1904
1906
1908
1916
1918
1919
1922
1923
1924
1941
1943
1945
1946
1947
1948
195
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
208
2081
2085
2086
209
2092
2133
2134
2135
2136
2138
2145
2146
2148
2149
2150
2151
2156
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
234
2353
239
243
2454
2469
248
2484
2496
2506
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
2741
2742
2753
2755
2760
277
2774
2821
2828
2829
2835
2840
2841
2842
2843
2844
2849
2855
2856
2857
2868
2869
2873
2874
2875
2876
2881
2883
2886
2888
2889
2890
2892
2896
2898
2899
2900
2901
2912
2920
2924
2925
2926
2929
2930
2933
2937
2938
2940
2943
299
310
314
315
316
320
322
323
326
334
336
337
348
351
352
369
371
379
380
383
386
389
394
404
406
412
424
430
435
440
442
444
445
446
447
448
450
452
453
456
470
473
474
476
483
484
489
494
498
499
505
511
51251061
513
518
520
527
531
533
542
560
562
565
568
570
574
577
578
579
580
583
585
589
590
596
597
601
605
606
613
615
633
639
642
643
644
649
650
651
655
656
66
666
669
67
671
675
676
68
685
686
689
69
690
691
694
695
70
718
731
732
733
735
740
741
751
756
757
758
76
760
766
767
768
782
787
788
789
790
791
792
796
797
814
815
823
828
84
846
848
851
852
855
856
858
859
86
861
865
878
88
888
892
893
894
909
919
92
920
923
924
925
926
93
934
935
939
943
948
95
950
951
952
953
954
959
963
964
971
973
974
975
976
986
989
99
990
D902-214-00
,
722028 - UDI-DI 00884838054202, 00884838059191, 00884838059269
Serial Numbers
1
1000
1001
1002
1004
1011
1014
1017
1022
1024
1030
1032
1034
1035
1041
1043
1049
1050
1051
1054
1058
1068
1069
1074
1076
1077
1081
1085
1094
1095
1098
1099
11
110
1100
1103
1111
1116
1122
1129
1130
1132
1136
1142
1149
1154
1155
1156
1168
1171
1187
1188
1189
1191
1200
1201
1202
121
1211
1212
1213
1214
122
1222
1232
1233
1244
125
1256
1261
1264
1266
1267
1269
127
1275
1279
128
1286
1288
129
130
131
1310
1311
132
1326
1327
133
1331
1333
1340
1343
1349
1350
1351
1352
1353
1359
136
1368
137
1370
1373
1374
138
1385
1387
139
1393
1394
1395
1396
1397
140
1405
1407
1408
141
1413
142
1424
1428
143
1439
1441
1446
1447
1448
145
1454
1456
1457
1461
1463
1466
1472
1481
1482
1483
1484
1498
1499
1508
151
1514
1522
1538
154
1549
155
1556
1566
1567
1568
1569
1570
158
159
1598
160
1600
161
1619
1629
1630
1633
1634
1639
1646
1649
1650
1651
1652
1656
1657
166
167
1677
169
1690
1705
1708
1710
1716
172
1723
173
1736
1751
1755
1756
176
1774
1783
180
1809
1811
1820
1822
1824
1826
1828
1834
1835
1836
1837
184
1845
1846
185
1850
1854
1855
1856
1869
1870
1875
1880
1889
189
1890
190
1909
1920
1930
1931
194
1945
1946
1948
1949
195
1956
1957
197
1978
1980
1983
1984
1988
1995
2007
2008
2020
203
204
205
206
2061
207
2070
2071
208
2083
209
210
2103
211
2110
213
215
2151
216
217
2173
2174
218
2192
2196
2200
2206
222
224
2249
2252
2253
2261
227
2275
228
2284
229
2293
2295
2310
2335
234
2348
236
237
238
2407
242
2422
2502
2506
251
254
256
257
260
2601
261
2615
262
2635
2641
2645
2647
265
267
2707
2709
2710
272
273
274
2745
275
2760
279
280
281
282
283
2834
284
2843
2846
289
2906
292
2922
2933
303
305
306
31
310
313
315
316
317
318
324
326
329
333
336
339
340
343
346
347
350
356
361
363
364
365
368
371
372
373
375
376
377
379
382
386
394
402
406
407
408
416
419
420
422
424
426
428
431
435
437
445
447
449
451
452
453
454
456
459
462
463
464
466
468
473
475
476
479
48
481
485
488
489
490
491
493
494
496
498
499
516
518
519
52
520
521
522
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
654
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
774
779
781
784
785
793
80
805
806
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
924
925
928
929
930
932
934
938
940
945
946
949
952
956
961
962
966
967
968
971
973
976
977
978
981
982
983
987
989
990
991
994
995
998
;
Allura Xper FD20 Biplane
722008 - no UDI
Serial Numbers
115
124
133
142
173
1789
19
197
231
246
264
267
288
306
312
319
349
378
419
420
445
453
463
465
472
487
491
516
521
,
722013 - UDI-DI 00884838059061 or 00884838080805
Serial Numbers
100
105
106
113
115
124
125
126
129
140
141
147
148
149
150
151
152
153
159
160
164
170
174
175
178
179
194
203
205
213
214
216
217
218
228
241
244
246
249
253
254
255
262
264
266
267
268
269
274
278
289
290
293
297
30
303
304
307
308
309
313
316
327
328
330
342
346
347
35
351
357
360
375
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
61
626
631
634
637
638
639
69
72
74
77
84
85
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
12
124
127
128
138
142
147
160
175
179
18
26
27
35
41
42
46
49
64
66
71
72
75
82
83
98
,
722035 - UDI-DI 00884838054240
Serial Numbers
100
101
117
119
121
123
124
125
126
127
131
143
145
147
161
165
169
172
183
187
192
196
21
212
216
222
236
24
242
243
244
245
246
247
252
30
34
38
46
47
52
57
59
60
72
74
85
88
89
;
Allura Xper FD20/10
722029 - UDI-DI 00884838054219
Serial Numbers
100
110
126
129
21
22
30
31
36
55
56
57
60
62
63
7
71
84
88
91
94
95
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
182
186
190
196
197
199
200
202
203
205
212
215
219
22
23
238
239
24
249
254
257
259
264
265
274
277
278
279
285
288
290
304
305
319
325
337
340
365
366
373
378
38
4
405
5
56
59
61
65
71
82
85
94
99
;
Allura Xper FD20/15 OR Table
722059 - UDI-DI 00884838059122
Serial Numbers
33
7
;
Allura Xper FD20/20
722038 - UDI-DI 00884838054226
Serial Numbers
106
108
115
118
119
120
126
130
131
137
141
157
167
173
35
37
38
39
41
42
46
48
49
55
60
62
63
67
7
70
71
78
96
99
;
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
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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.
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510(K) Database | 510(K)s with Product Code = OWB 510(K)s with Product Code = OWB 510(K)s with Product Code = OWB 510(K)s with Product Code = OWB
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