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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips Azurion and Allura Systems Recalled for Power Supply Shutdown Risk

Agency Publication Date: September 3, 2025
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Summary

Philips is recalling approximately 2,867 Azurion and Allura medical imaging systems configured with a 1 Phase Uninterruptible Power Supply (UPS). These systems have a potential defect where they may shut down unexpectedly or fail to restart if power is lost, which could disrupt critical medical procedures. The recall affects a total of 1,861 Azurion units and 1,006 Allura units distributed worldwide, including across the United States.

Risk

If the system loses power and fails to restart or shuts down improperly during a medical procedure, it could lead to delays in diagnosis and treatment, potentially endangering patients. There is a risk that the imaging system will not be available when needed most during clinical interventions.

What You Should Do

  1. This recall involves Philips Azurion and Allura medical imaging systems that are equipped with a 1 Phase Uninterruptible Power Supply (UPS).
  2. Identify whether your system is affected by checking the model number and serial number located on the device identification label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical device immediately and coordinate with your facility's clinical engineering or laboratory supervisor.
  4. Contact Philips Medical Systems Nederland B.V. or your authorized distributor to arrange for a system correction, technical inspection, or replacement of the affected power components.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips Azurion 3 M12
Model / REF:
722063
722221
Serial Numbers:
25
151
91
85
90
86
107
89
88
87
120
153
96
108
19
49
115
171
6
8
127
59
56
126
106
166
155
UDI:
00884838085275
00884838099203
Product: Philips Azurion 3 M15
Model / REF:
722064
722222
Serial Numbers (61):
64
260
261
335
218
267
270
258
35
10
111
82
125
94
278
36
55
12
57
69
484
451
497
155
272
490
132
70
251
226
290
186
48
373
23
44
45
187
223
99
100
101
332
51
65
11
268
188
77
80
UDI:
00884838085282
00884838099210
Product: Philips Azurion 7 B12
Model / REF:
722067
722225
Serial Numbers (92):
150
69
221
148
42
98
123
277
92
103
41
214
173
172
163
128
151
22
23
268
112
97
243
45
108
113
127
176
165
33
30
206
203
48
149
251
262
259
55
147
340
72
71
216
299
291
289
249
110
298
UDI:
00884838085350
00884838099265
Product: Philips Azurion 7 B20
Model / REF:
722068
722226
Serial Numbers (203):
213
111
85
89
320
73
308
172
295
406
285
413
322
324
184
442
279
361
490
42
103
520
470
472
457
400
547
510
239
275
265
365
481
62
552
44
158
36
276
68
551
516
372
46
185
515
347
416
242
219
UDI:
00884838085367
00884838099272
Product: Philips Azurion 7 M12
Model / REF:
722078
722223
Serial Numbers (352):
465
143
278
402
290
524
412
166
539
532
291
415
753
441
305
289
803
399
536
537
478
479
224
163
719
364
239
383
829
513
661
215
677
709
410
269
185
902
360
546
294
906
603
870
523
598
317
535
359
436
UDI:
00884838085251
00884838099241
Product: Philips Azurion 7 M20
Model / REF:
722079
722224
722282
Serial Numbers (901):
942
948
702
703465
1316
1042
465
674
703413
1142
1090
526
439
637
455
334
875
737
599
29
704281
801
671
1387
981
1211
1213
499
1230
708
496
903
887
912
1041
703324
528
703584
738
351
820
32
1411
537
445
428
587
1290
251
1402
UDI:
00884838085268
00884838099258
00884838110571
Product: Philips Azurion 5 M12
Model / REF:
722227
Serial Numbers:
88
135
261
19
133
134
241
164
82
32
16
12
72
64
242
176
2
75
145
143
120
112
74
188
147
146
77
141
234
14
15
47
95
163
48
3
1
123
92
173
174
121
204
57
282
8
9
UDI:
00884838099227
Product: Philips Azurion 5 M20
Model / REF:
722228
Serial Numbers (52):
187
328
113
205
204
150
159
23
127
24
10
36
6
213
64
20
26
47
149
62
502
18
125
391
395
229
12
408
309
310
557
98
261
179
536
143
46
70
7
13
191
259
218
11
223
370
389
14
71
39
UDI:
00884838099234
Product: Philips Allura Xper FD10
Model / REF:
722003
722010
722026
Serial Numbers (242):
1225
789
1138
445
740
152
1411
911
1180
936
338
660
411
992
1210
873
1028
921
287
825
462
192
74
191
204
155
967
1132
205
1246
253
156
234
233
845
122
259
185
618
531
855
235
335
1068
843
805
646
965
258
220
UDI:
00884838059030
00884838054189
Product: Philips Allura Xper FD10/10
Model / REF:
722005
722011
722027
Serial Numbers (60):
35
308
203
123
133
284
134
222
255
106
107
234
42
179
306
307
265
267
40
332
112
305
104
231
263
342
71
351
298
116
50
29
39
49
56
152
153
202
164
160
64
99
101
254
84
297
268
77
115
114
UDI:
00884838059047
00884838054196
Product: Philips Allura Xper FD20
Model / REF:
722006
722012
722028
Serial Numbers (538):
168
2198
2184
2606
195
161
1956
2256
2070
1502
376
1096
1731
525
823
1141
1078
1811
2092
1641
114
2134
1589
1446
1675
1625
1989
2156
455
233
2929
2930
749
1080
149
854
596
819
1598
316
1946
541
565
647
864
710
946
949
880
1041
UDI:
00884838059054
00884838054202
Product: Philips Allura Xper FD20 Biplane
Model / REF:
722008
722013
Serial Numbers:
246
2470
580
254
78
357
428
UDI:
00884838059061
Product: Philips Allura Xper FD20 OR Table
Model / REF:
722023
722035
Serial Numbers:
164
66
85
24
101
117
21
38
177
121
183
88
57
125
119
100
165
47
52
131
124
169
46
74
30
60
59
196
216
187
34
222
72
111
128
1
96
53
160
104
191
70
154
142
134
129
65
UDI:
00884838059085
00884838054240
Product: Philips Allura Xper FD20/10
Model / REF:
722029
Serial Numbers:
91
71
110
126
21
62
88
36
100
30
63
60
94
95
56
31
107
43
UDI:
00884838054219
Product: Philips Allura Xper FD20/20
Model / REF:
722038
Serial Numbers:
39
63
42
55
78
99
60
71
115
108
67
106
118
130
49
119
126
46
37
38
48
62
35
120
41
157
96
70
137
166
34
116
72
64
UDI:
00884838054226
Product: Philips Allura Xper FD20/15
Model / REF:
722058
Serial Numbers:
337
22
202
71
239
186
56
24
168
129
123
259
134
38
171
264
61
99
162
65
278
277
196
23
205
212
111
49
89
150
177
60
131
377
206
106
223
229
288
169
125
126
320
139
213
UDI:
00884838059115
Product: Philips Allura Xper FD20/15 OR Table
Model / REF:
722059
Serial Numbers:
7
8
UDI:
00884838059122

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97249
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Medical supply distributors; Healthcare facilities
Manufactured In: Netherlands
Units Affected: 2 products (1,861 units; 1,006 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.