FDA recall, Posted Oct 27, 2026, Moderate risk

Philips Azurion 3, 5, and 7 Systems

Philips Azurion systems may have solid-state drives not specified in the Medical Device File, causing loss of imaging or access to images.

Summary by Recall Canary from the FDA notice

Philips Medical Systems Nederland B.V., based in Best, Netherlands, voluntarily recalled certain Philips Azurion products because solid-state drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs.

These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

The recall began on October 6, 2026, and was added to the FDA's Enforcement Report on October 27, 2026, with classification on the same date.

The affected products include Philips Azurion S, Azurion 7 B20, Azurion 7 M20, Azurion 5 M12, Azurion 5 M20, Azurion 3 M15, Azurion 3 M12, Azurion 7 M12, and Azurion 7 B12, with distribution worldwide, including US nationwide and many other countries. Customers were told by letter.

More device defect recalls

What to do

The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:

A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
Talk to your health care provider before you stop using it.

Is yours affected?

9 products

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

Philips Azurion 3 M15.
1. Model
  722064
  UDI-DI
  00884838125681
2. UDI-DI
  00884838085282
  Model code
  722064
  722222
  722280.
  Serial number
  258
  229
  291
  218
  335
  161
  169
  297
  479
  190
  268
  220
  375
  173
  359
  256
  290
  502
  130
  157
  264
  263
  253
  254
  280
  102
  467
  421
  510
  345
  212
  266
  180
  185
  193
  214
  271
  213
  431
  246
  354
  374
  106
  231
  287
  176
  149
  197
  289
  288
  All 309
  150
  233
  230
  380
  448
  323
  278
  125
  484
  104
  155
  422
  132
  183
  439
  446
  138
  321
  293
  292
  379
  151
  237
  520
  519
  208
  462
  342
  222
  391
  441
  320
  494
  109
  101
  311
  442
  485
  121
  384
  252
  124
  191
  122
  119
  309
  400
  251
  480
  387
  111
  147
  509
  454
  478
  262
  491
  133
  476
  337
  275
  468
  412
  508
  414
  405
  396
  247
  310
  517
  394
  432
  504
  426
  304
  469
  340
  393
  343
  458
  322
  444
  395
  385
  505
  472
  514
  236
  471
  401
  234
  503
  407
  470
  498
  413
  440
  463
  330
  475
  473
  501
  308
  225
  483
  474
  344
  389
  492
  324
  265
  235
  120
  496
  427
  341
  100
  123
  177
  250
  174
  452
  168
  447
  182
  198
  206
  312
  403
  386
  397
  500
  226
  408
  381
  488
  416
  404
  285
  515
  449
  477
  338
  215
  164
  114
  144
  327
  227
  295
  294
  319
  241
  126
  284
  175
  419
  372
  429
  296
  172
  283
  357
  306
  437
  210
  315
  134
  255
  207
  192
  116
  221
  189
  117
  313
  187
  166
  135
  108
  722222
  318
  269
  316
  307
  346
  362
  336
  339
  390
  368
  141
  224
  383
  351
  373
  361
  118
  209
  331
  145
  305
  369
  245
  353
  178
  142
  105
  228
  364
  333
  219
  282
  370
  115
  186
  181
  184
  276
  159
  158
  722280
  179
  249
  232
  113
  167
  165
  128
  240
  131
  223
  139
  259
  188
  171
  243
  127
  143
  152
  260
  273
  277
  216
  129
  170
  239
  248
  205
  261
  196
  110
  199
  140
  257
  286
  103
  160
  137
Some entries omit identifying details. Check the notice to confirm which units are affected.
Philips Azurion 5 M12.
Model
722227
UDI-DI
00884838099227
Philips Azurion S.
Model
722285
Philips Azurion 7 B20.
UDI-DI
00884838085367
Model code
722068
722226.
Serial number
178
147
205
170
494
247
149
153
320
172
505
271
443
354
196
285
406
528
350
462
319
520
117
143
469
361
114
477
232
107
282
276
608
473
417
302
126
211
468
410
466
495
167
537
173
289
233
536
204
313
All 408
237
133
481
307
577
210
258
328
199
480
491
423
509
246
614
539
257
369
508
303
550
460
551
478
522
238
544
230
434
306
192
215
447
316
552
570
387
134
560
158
518
318
250
118
185
206
489
521
254
534
292
497
293
359
527
129
128
396
334
425
415
471
540
584
553
602
240
617
604
589
612
556
557
574
603
601
609
616
597
605
575
516
624
563
590
548
420
475
180
414
349
519
234
219
195
533
398
618
549
531
426
290
326
286
124
362
317
571
331
273
188
264
122
300
100
253
391
226
315
252
175
186
409
298
368
722226
209
675
1091
113
1145
1078
197
687
680
280
343
332
341
1162
554
337
400
757
323
262
1017
379
786
573
458
987
880
141
693
510
882
1157
1050
367
184
179
1139
1062
1121
950
176
712
829
249
576
1046
708
738
1083
1098
717
1126
665
764
386
977
721
1006
682
789
698
1097
1094
378
808
718
412
715
1143
775
1073
982
958
222
430
1067
810
1114
314
762
1102
978
1060
920
1136
836
835
795
800
899
838
944
1123
335
1039
203
731
725
701
967
501
992
119
732
974
919
686
523
327
1049
993
259
909
142
263
422
1057
1103
164
485
1155
1054
366
1140
1048
752
1088
906
299
284
404
283
401
833
895
224
1087
395
444
710
820
235
846
727
1026
1129
777
431
696
1099
438
630
941
429
854
888
596
957
645
739
736
1127
1117
251
1000
965
1160
1042
699
1064
741
740
1137
900
901
887
949
632
1112
1156
737
907
825
877
1134
1161
648
831
1116
1149
1104
860
798
938
773
939
1065
716
1133
672
1109
1124
995
813
1163
580
384
896
636
720
742
832
902
867
872
418
231
1035
1055
745
1033
1105
637
953
546
844
649
855
288
137
811
652
Philips Azurion 7 M20.
UDI-DI
00884838085268
Model code
722079
722224
722282.
Serial number
1023
646
703904
890
1137
1048
401
536
1054
1010
266
617
246
905
809
848
1033
836
466
1155
673
564
1032
1117
820
1211
1213
1365
881
774
955
633
703540
296
574
842
884
991
703336
753
703493
790
481
407
408
877
703395
703323
483
241
All 1725
1108
1363
1414
703404
703387
1355
863
350
908
1378
262
598
275
520
593
1018
1432
594
999
361
526
1021
608
611
413
895
428
883
758
274
525
885
843
754
703528
599
1171
817
766
878
1170
703310
944
703305
1285
854
730
703497
957
658
1022
621
628
795
1007
1289
605
1222
769
938
655
1311
538
989
946
888
402
1042
374
459
1282
841
703532
1360
1359
1358
326
216
927
981
923
1163
416
424
802
751
436
910
1242
251
1156
1049
1103
1361
1041
930
228
366
543
921
1200
359
355
357
356
1090
801
474
1187
247
742
222
537
351
777
898
703317
653
684
746
998
668
706
847
879
703308
837
387
417
1393
212
290
669
239
800
703584
595
1059
1382
1381
747
663
703333
862
703345
427
1100
327
602
937
1201
702
333
352
284
679
1374
750
783
703813
704301
780
704114
703719
217
816
214
1280
703565
704304
719
704059
729
943
337
704184
704240
704242
703662
1340
703823
1026
377
380
379
662
703449
258
260
451
703699
259
703355
703654
703870
395
433
1405
703999
1047
1241
752
703375
1319
703712
703326
703655
703702
703939
531
703802
703897
704203
1389
703953
1053
703600
570
703769
704026
703753
703967
704112
984
703807
703529
1073
704154
778
548
798
704037
316
703669
1429
704209
722
703619
704142
600
825
452
969
1020
703358
1095
703487
704092
461
765
578
703572
982
703462
703583
1106
1044
703855
703348
703872
855
1030
1120
703959
703489
913
304
303
704101
305
1194
703961
1337
993
347
1074
230
293
421
434
961
1185
703477
257
661
704146
703982
1442
1441
1440
704211
703812
703423
1317
1264
1278
703313
703544
703749
1347
958
951
484
703470
542
235
486
700
348
703867
1154
703965
704239
703993
703542
551
550
703526
704085
704079
703485
547
371
485
596
1052
703804
703906
703596
703937
1288
703954
1183
368
704262
703556
902
1422
571
278
703754
457
722079_703569
704081
704103
704019
1119
960
703424
704023
704119
1015
1351
1076
1129
704030
704126
956
703819
704036
703690
703648
703709
704207
703728
703826
381
703794
703607
703574
762
703743
703632
703913
703889
703700
704246
704054
703606
703473
703346
521
703750
703990
703834
703727
586
965
498
789
728
291
703482
703693
703533
967
475
704067
349
784
704274
703506
233
704144
704167
704168
698
643
642
1210
435
704070
1077
450
703614
703973
704110
703701
703628
703948
703955
703665
1367
703899
704202
703641
703711
704173
703856
703842
703651
704186
704269
704074
704108
703821
704134
704029
703601
703979
703777
703741
704041
703778
703670
703650
703646
703846
703945
704021
703909
703908
704031
704271
703756
703618
703724
704060
704120
704017
703921
703816
703988
703573
703997
703674
703673
703591
704002
703733
703735
703986
703940
703757
703751
703883
704139
704157
704265
704279
704289
704280
704024
703911
703912
703605
703797
704022
704039
703471
704095
703663
704138
703604
704247
703707
704008
704221
703799
703576
704009
704069
703840
704080
703998
704012
703603
704130
703786
704131
704078
703630
704066
703983
703507
704001
703645
703919
704196
704197
703616
704201
704133
703796
703857
703859
703863
703858
703860
703780
704166
703642
703640
704093
704259
703680
703878
703901
704020
703884
703958
704091
1376
977
1093
703975
704113
704090
704147
703571
703703
703887
703923
704145
704215
704111
704217
704124
703585
704094
703759
703639
703647
703627
704064
704050
704255
704175
703697
1263
703894
703895
703891
704181
704180
704007
703789
704075
703827
703587
704056
704122
703876
703989
704046
703679
703924
704223
704051
703934
1287
704216
704267
704177
703825
704115
703836
703932
703661
704152
703831
704132
703548
704200
703666
703730
703837
1167
703798
703818
704096
704151
703725
704178
704161
704014
703977
704082
704089
703888
703930
703928
703929
703931
703974
703881
704252
703941
703917
703667
703668
704153
703617
704169
704219
704275
703625
703660
704104
704128
704065
1228
704116
704102
703898
703636
703843
704264
703692
703664
703555
704218
704109
1224
1225
704125
703684
703742
703723
703635
704206
703910
703553
704189
703951
704098
703539
703541
703678
1034
703900
703893
703761
756
786
390
398
703653
1046
1255
665
667
317
703715
1253
703414
456
941
703505
392
544
323
703658
704135
704149
1332
703873
704010
704057
1357
703459
703944
952
676
703720
703892
410
703985
338
906
1349
703579
703810
704303
703694
703874
1188
764
759
704015
703675
703970
703877
704117
703956
704084
704213
467
276
670
1384
704188
703717
703922
796
704016
703729
704243
695
616
1139
775
703372
703440
703502
582
494
703377
405
562
703952
704018
703957
704033
704032
703695
703475
703947
704063
703890
703589
704204
703536
703849
703659
704025
703926
703978
703991
704260
703987
704250
704195
703672
703468
703467
703652
703714
703481
419
724
1057
771
1339
1176
1160
703490
703631
703549
703443
1025
1336
703339
1161
703352
1131
1091
1390
1178
703649
703531
703762
703763
703534
703705
703706
703704
703554
703444
703353
1058
703787
1075
703431
827
1024
703410
844
1094
1069
703522
703354
703590
1180
1067
723
1159
703795
703570
703454
703721
703722
1173
703422
703518
1404
1437
1092
703484
703325
568
1207
703865
703403
1068
1099
703519
1126
703916
703907
703451
1071
1307
612
703373
277
917
225
256
918
640
864
288
794
692
703363
980
703452
463
541
893
1145
373
929
609
722224
409
2744
3526
1484
1083
3514
2241
962
2520
1692
2421
2432
287
904
3211
1874
901
3067
514
553
2390
618
2879
3642
859
2759
3490
3582
1706
566
565
2559
2993
3020
224
153
656
650
2723
2911
1318
1039
2649
1679
3046
3048
850
1082
273
306
3453
3283
1488
966
2594
1940
2656
867
244
2793
1975
2901
105
856
3373
963
151
657
3145
215
516
478
770
3525
1175
3486
3603
339
103
3794
3341
1606
2549
2435
587
112
2548
507
2377
2572
492
2226
1935
3224
1782
2452
252
2453
300
2279
2220
1526
2869
839
3258
462
3516
2655
188
2369
2301
2130
165
1551
627
1383
3026
2965
2967
1999
2000
2199
2340
3270
169
3053
332
517
2427
845
3579
1499
3205
404
2957
253
1243
2367
1493
3527
3454
3189
979
787
441
949
3673
2557
581
185
3401
2733
1527
503
1335
874
875
3596
495
2667
3459
1622
1089
353
1568
2852
2931
2742
3474
1988
1974
1851
2804
2933
2777
1709
1705
1942
1802
3696
2772
2089
1686
1670
2186
2546
3792
2513
3105
942
1609
2244
2373
3099
3264
1330
1350
1369
3473
1326
2245
1970
776
3117
799
1747
1385
2405
1812
1204
1529
2060
3334
2583
2479
3502
2555
1005
2044
3522
2025
1151
1164
2561
1027
2509
2588
3347
1449
501
3428
546
1475
2586
1470
2496
2464
2585
2959
3597
3255
828
1502
2515
3631
1344
1619
2238
720
2630
1581
1138
2732
1424
3653
1949
675
2696
3005
2307
3546
1412
3629
2467
1104
499
530
2560
1002
1704
3479
2592
3183
3641
1368
3227
1522
3660
2320
887
687
2709
1474
532
1306
1647
1153
1991
2866
2923
2864
2865
3311
1281
2566
3752
3598
2947
3665
3411
3666
3753
3383
2745
2738
2527
686
3225
2715
3724
3754
3729
1711
3570
707
708
575
1785
1862
1549
3216
2943
1427
1406
2310
171
2347
1051
1050
1348
2277
1080
2751
2605
2987
145
2534
1799
2692
2953
3236
2998
3634
1840
829
3111
264
1919
3701
1667
2431
3318
2713
3191
3648
3197
768
449
448
1875
3533
1463
3535
2097
1800
3259
358
2224
3118
489
2760
1742
2476
2429
1114
3232
3252
3498
635
2538
2157
1366
3319
3799
1272
460
2781
3412
990
1446
716
1498
2643
2444
2286
2360
2674
2485
3655
2780
412
2191
508
804
3481
2936
2490
2489
3427
1040
2272
2460
1676
2845
1205
1761
3234
985
2446
156
1809
2678
1420
3790
1434
2312
2402
1673
2357
1665
1824
1655
3263
3317
2887
3586
3718
1927
1553
3109
2380
1413
1127
2123
1732
1448
2791
1788
2632
1500
3583
2956
3226
1513
1198
2660
3517
1819
1607
1418
2471
1631
2115
2666
1599
2940
2941
1489
1497
1971
1990
3002
2796
2024
3056
2225
2702
1674
2408
2822
1941
2607
1825
2387
2388
3552
1520
1696
2216
2894
2020
2019
3103
1729
3765
3599
3431
3080
2821
2116
1979
2491
1202
2372
3041
1754
2333
2040
1658
1152
3611
2726
3421
3254
3434
2808
2762
2807
2761
2763
1292
2173
1822
1641
1291
2697
1532
2695
2118
2290
1749
2109
2639
2766
3773
2249
2890
2469
2067
2065
1752
1755
2826
2382
3798
3689
1996
1848
1844
1989
1841
2059
3731
772
773
1950
2273
2295
3703
2023
2053
1166
1070
3743
2200
3783
1849
2428
1503
1847
1846
3024
3585
2313
2992
1746
3566
2470
1983
2379
2934
2066
2543
2292
3402
1675
2256
2158
2798
1135
1293
2117
2824
2701
3702
2815
2794
1744
2461
2110
1818
2041
2393
2090
2463
2468
2898
2966
2147
2136
3116
1858
2551
1423
1770
1944
3630
3260
3704
3706
3705
1417
2179
1748
1987
2922
1820
2392
1531
3059
1464
1867
1191
1920
1695
3220
2033
2108
2206
3182
1616
1451
2895
2827
1769
1778
2851
2964
3511
3445
3567
3782
3796
3797
3826
3837
3822
3785
3827
690
660
3440
1521
2684
1016
529
3076
2848
528
2361
3381
1261
2638
221
1671
1834
3010
1868
3013
3014
3266
3261
1733
2814
375
1617
3595
2163
1530
1626
2048
3339
978
1401
3574
203
2344
3237
2756
1284
2309
3012
3321
2670
393
2252
2625
2716
2137
1148
2568
2482
2944
1248
2161
1528
2455
1501
3394
1290
2422
781
3368
1683
1741
2757
1823
2008
3739
1373
1480
3749
688
1227
697
2006
699
1428
3778
2517
743
3774
2909
3396
705
1465
1552
1496
1792
168
3679
197
2973
889
722282
154
133
116
120
118
117
178
187
195
194
149
162
189
173
143
142
130
166
114
193
144
198
172
128
135
136
163
191
109
132
160
175
158
155
148
125
139
102
157
161
174
150
199
100
Philips Azurion 5 M20.
UDI-DI
00884838099234
Model code
722228
722281.
Serial number
159
180
273
132
533
522
153
431
113
529
659
145
567
539
645
308
333
335
570
560
569
418
280
616
568
471
428
465
102
176
103
178
109
234
566
571
463
647
317
562
552
680
724
561
517
203
773
260
107
100
All 332
108
640
101
318
602
531
574
370
464
580
496
668
223
312
218
513
442
548
174
486
487
346
172
217
575
697
196
676
677
118
415
452
179
331
297
412
427
488
500
588
443
663
747
754
621
766
739
498
743
707
738
755
708
284
742
725
565
745
201
457
458
690
171
229
332
306
610
646
429
601
257
608
763
590
591
628
197
366
345
627
302
166
432
356
357
305
620
220
325
545
405
514
341
342
184
426
497
183
195
282
490
421
440
446
320
281
480
364
448
283
473
321
476
681
409
535
519
384
489
361
787
303
413
785
765
512
437
656
336
200
504
494
667
408
532
698
449
438
453
106
311
459
477
330
167
549
784
390
261
334
337
467
304
212
340
515
173
219
160
634
732
133
733
208
165
378
685
164
228
701
401
161
147
723
691
730
146
170
295
290
316
207
686
119
722281
379
233
391
278
140
338
328
129
417
521
402
444
115
125
339
351
210
188
419
542
236
307
350
410
105
344
225
186
352
117
396
270
371
157
389
168
204
466
447
310
155
485
468
430
126
450
365
377
406
276
327
226
156
407
434
291
221
367
289
363
326
323
251
222
121
134
510
374
414
501
454
242
206
518
263
193
137
439
579
502
163
111
368
479
411
185
483
142
128
506
478
505
507
475
262
248
288
Philips Azurion 3 M12.
UDI-DI
00884838085275
00884838099203
Model code
722063
722221.
Serial number
145
146
117
104
144
153
121
101
143
151
150
105
129
139
154
100
106
135
123
133
140
148
113
722221
115
177
124
159
142
126
147
167
202
165
174
176
207
Philips Azurion 7 M12.
UDI-DI
00884838085251
Model code
722078
722223.
Serial number
302
585
293
613
546
479
278
456
571
921
165
656
657
576
121
383
239
645
379
399
803
296
559
538
166
257
258
684
359
143
661
520
187
269
522
677
709
535
170
723
298
305
725
728
524
290
384
360
906
294
All 521
240
603
719
163
271
412
627
748
497
483
309
232
635
612
205
206
204
218
444
986
135
589
977
380
356
344
343
943
898
482
764
772
770
771
773
191
982
981
980
235
139
511
178
179
526
265
264
266
746
287
1003
897
960
1036
375
374
142
934
835
975
929
836
681
1072
1070
1069
1071
893
382
324
849
347
346
648
1058
1068
339
340
688
687
846
424
800
838
156
150
485
726
727
1039
962
769
570
698
683
541
1025
672
912
578
504
398
743
729
449
429
757
818
419
328
223
584
468
855
918
919
277
976
577
498
574
451
428
175
460
459
718
944
669
112
338
440
181
920
336
226
990
839
354
957
471
357
789
140
878
988
806
950
652
349
1005
236
831
501
841
905
682
843
830
323
315
680
365
675
369
615
352
193
280
667
749
407
505
408
157
752
138
463
461
252
169
650
426
442
351
968
529
750
259
579
926
597
899
978
418
909
601
1033
1035
1009
1047
984
989
987
907
1085
1048
1059
1061
1034
1080
875
1026
717
716
1015
1045
946
942
945
947
940
948
1052
971
994
701
1075
1046
970
985
798
710
1011
1065
1067
1064
1066
1056
992
663
1057
965
964
1043
736
735
819
820
1049
381
624
775
776
421
760
614
864
837
458
281
659
991
103
126
778
363
472
782
961
643
857
636
447
619
527
600
434
892
124
201
495
515
303
304
518
616
972
1032
1051
575
939
869
874
871
1010
1029
1030
551
1013
543
516
416
446
685
715
913
582
908
435
508
530
198
722223
533
1146
1138
439
1088
799
1060
1107
261
1231
883
889
665
1323
105
211
1211
161
1296
130
1150
888
119
1131
1115
348
1325
132
814
1214
812
904
1167
1232
591
587
1248
322
756
1016
1256
694
537
1055
134
1222
393
550
848
137
868
823
1284
1104
480
521
525
519
858
523
821
862
1041
202
492
1207
1301
924
437
438
436
1327
331
1267
1246
270
376
851
894
445
791
807
1275
1336
554
194
954
1151
1092
583
413
1190
664
666
787
1141
443
860
534
1073
1270
1122
1124
1274
692
766
900
517
1172
1176
1304
689
686
1171
634
1347
1198
1334
651
1322
1321
1225
762
758
763
765
767
953
644
1228
662
655
255
536
625
1007
241
808
1340
1338
1341
983
1209
1335
1201
182
958
510
1208
1260
320
319
300
276
493
1062
653
Philips Azurion 7 B12.
UDI-DI
00884838085350
Model code
722067
722225.
Serial number
173
172
109
250
114
214
221
278
131
141
133
128
151
233
255
256
270
238
187
154
157
251
237
222
262
209
260
191
274
218
231
169
275
211
213
210
212
265
190
268
203
138
140
143
142
144
266
235
272
273
All 160
156
276
271
202
149
207
226
264
102
105
159
186
170
193
229
175
167
198
118
119
110
178
139
722225
479
474
354
455
284
468
232
269
230
345
296
374
246
241
180
367
450
292
145
475
306
469
437
338
465
457
314
426
420
422
421
290
267
454
418
478
438
366
301
146
414
200
189
387
372
254
312
320
392
423
393
373
456
206
442
327
447
446
448
242
459
135
134
395
427
116
439
107
477
313
346
476
471
472
253
411
252
351
234
342
480
348
386
125
341
162

Recall details

Posted by FDA

Oct 27, 2026

Recall began

Oct 6, 2026

Status

Open

Weekly archive

Listed the week of Oct 26, 2026

Sold in

US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

Recalled by

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands

Hazard

Device defect

Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

FDA event number

99939

Recall numbers

Z-0292-2027 to Z-0300-2027

Recall type

Voluntary: Firm initiated

How the company first told customers

Letter

All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.

Oct 6, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began the recall
Oct 27, 2026
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Oct 28, 2026
Added to Recall Canary
Oct 31, 2026
Summary updated

What happened

What to do

Is yours affected?

Philips Azurion 3 M15.

Philips Azurion 5 M12.

Philips Azurion S.

Philips Azurion 7 B20.

Philips Azurion 7 M20.

Philips Azurion 5 M20.

Philips Azurion 3 M12.

Philips Azurion 7 M12.

Philips Azurion 7 B12.

Recall details

Timeline

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