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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 MEDICAL SYSTEMS NEDERLAND B.V.: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Agency Publication Date: March 27, 2026
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Summary

Philips is recalling approximately 20,389 Allura and Azurion X-ray Systems because the systems may fail to start X-ray imaging or may only work intermittently when using the wired foot switch. This defect could cause unexpected interruptions or delays during critical medical procedures performed in hospitals. No incidents or injuries have been reported to date. These professional medical imaging systems were sold nationwide and internationally through authorized medical distributors and direct hospital sales.

Risk

The mechanical failure or intermittent signal from the wired foot switch prevents the initiation of X-ray imaging. If this occurs during a surgical or diagnostic procedure, it could lead to procedural delays and potential harm to the patient due to lack of real-time guidance.

What You Should Do

  1. Check your medical equipment for affected Philips system codes, including 722003, 722010, 722026, 722064, 722222, 722230, 722280, 722079, 722224, 722234, 722282, 722059, 722078, 722223, 722233, 722068, 722226, 722236, 722228, 722232, 722281, 722006, 722012, 722028, 722022, 722033, 722008, 722013, 722063, 722221, 722229, 722002, 722058, 722038, 722005, 722011, 722027, 722227, 722231, 722015, 722023, 722035, 722001, 722020, 722025, 722029, 722039, 722067, 722225, or 722235.
  2. Locate the system serial number on the identification plate of the X-ray unit to confirm if it matches one of the thousands of affected units (e.g., 445, 1123, 683, 302, 547, or 1023).
  3. Immediately report any instances of intermittent imaging failure when using the wired foot switch to your facility's biomedical engineering or technical support department.
  4. Contact Philips Medical Systems Nederland B.V. at their headquarters at Veenpluis 6, Best, Netherlands, or through your local authorized distributor for technical support and corrective action guidance.
  5. Contact your healthcare provider if you have questions regarding procedures performed using these systems.
  6. For further information or to report a safety issue, contact the FDA hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action and instruction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ALLURA Xper FD10
Model / REF:
722003
722010
722026
UPC Codes:
00884838059030
00884838054189
Lot Numbers:
445
1555
1084
1123
932
239
683
155
1051
Product: Azurion 3 M15
Model / REF:
722064
722222
722230
722280
UPC Codes:
00884838085282
00884838099210
00884838116733
00884838103276
Lot Numbers:
209
238
201
332
111
254
40
2
22
57
161
43
Product: Azurion 7 M20
Model / REF:
722079
722224
722234
722282
UPC Codes:
00884838085268
00884838099258
00884838116771
00884838110571
Lot Numbers:
1023
645
646
1229
450
1576
163
327
780
57
54
66
Product: Allura Xper FD20/15 OR Table
Model / REF:
722059
UPC Codes:
00884838059122
Lot Numbers:
33
7
35
40
38
41
37
2
Product: Azurion 7 M12
Model / REF:
722078
722223
722233
UPC Codes:
00884838085251
00884838099241
00884838116764
Lot Numbers:
302
585
410
312
324
332
64
122
169
Product: Azurion 7 B20
Model / REF:
722068
722226
722236
UPC Codes:
00884838085367
00884838099272
00884838116788
Lot Numbers:
547
178
467
120
122
123
127
37
159
Product: Azurion 5 M20
Model / REF:
722228
722232
722281
UPC Codes:
00884838099234
00884838116757
00884838110564
Lot Numbers:
67
524
49
5
33
34
125
176
233
Product: ALLURA Xper FD20
Model / REF:
722006
722012
722028
UPC Codes:
00884838059054
00884838054202
Lot Numbers:
1706
1730
1936
481
423
1506
1756
1569
1956
Product: ALLURA Xper FD10 OR Table
Model / REF:
722022
722033
UPC Codes:
00884838059078
00884838054233
Lot Numbers:
6
1
Product: ALLURA Xper FD20 Biplane
Model / REF:
722008
722013
UPC Codes:
00884838059061
Lot Numbers:
360
361
445
293
424
100
Product: Azurion 3 M12
Model / REF:
722063
722221
722229
UPC Codes:
00884838085275
Lot Numbers:
122
56
64
181
3
7
22
9
40
Product: ALLURA Xper FD10F
Model / REF:
722002
Lot Numbers:
53
61
78
38
28
63
3
81
66
40
Product: Allura Xper FD20/15
Model / REF:
722058
UPC Codes:
00884838059115
Lot Numbers:
100
239
305
259
203
373
111
38
23
290
Product: Allura Xper FD20/20
Model / REF:
722038
UPC Codes:
00884838054226
Lot Numbers:
71
115
42
108
173
119
60
37
38
99
Product: ALLURA Xper FD10/10
Model / REF:
722005
722011
722027
UPC Codes:
00884838059047
00884838054196
Lot Numbers:
321
285
490
49
137
375
351
332
1
Product: Azurion 5 M12
Model / REF:
722227
722231
UPC Codes:
00884838099227
00884838099258
Lot Numbers:
265
135
88
13
52
49
Product: ALLURA Xper FD20 OR Table
Model / REF:
722015
722023
722035
UPC Codes:
00884838059085
00884838054240
Lot Numbers:
12
16
2
49
41
142
119
126
169
Product: Allura Xper FD10C
Model / REF:
722001
Lot Numbers:
19
249
21
18661014
77
82
195
216
337
37
258
283
15
256
305
Product: ALLURA Xper FD20 Biplane OR Table
Model / REF:
722020
722025
UPC Codes:
00884838059108
Lot Numbers:
4
6
2
3
Product: Allura Xper FD20/10
Model / REF:
722029
UPC Codes:
00884838059078
Lot Numbers:
57
7
88
56
126
94
Product: Allura Xper FD20/20 OR Table
Model / REF:
722039
UPC Codes:
00884838054271
Lot Numbers:
4
2
5
8
6
Product: Azurion 7 B12
Model / REF:
722067
722225
722235
UPC Codes:
00884838085350
00884838099265
00884838116788
Lot Numbers:
221
42
172
104
153
46
77
127
76

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98434
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Manufactured In: Netherlands
Units Affected: 22 products (15 units (7 US, 8 OUS); 10 units (8 US, 2 OUS); 2291 units (493 US, 1798 OUS); 112 units (138 US, 422 OUS); 5084 units (1616 US, 3468 OUS); 461 units (198 US, 263 OUS); 196 units (73 US, 223 OUS); 4 units (2 US, 2 OUS); 2 units (1 US, 1 OUS); 85 units (20 US, 65 OUS); 111 units (31 US, 80 OUS); 5 units (OUS only); 296 units (68 US, 228 OUS); 2 units (2 US, 6 OUS); 298 units (27 US, 271 OUS); 798 units (42 US, 756 OUS); 670 units (106 US, 564 OUS); 1523 units (322 US, 1201 OUS); 1994 units (360 US, 1634 OUS); 5167 units (1728 US, 3439 OUS); 345 units (10 US, 335 OUS); 920 units (168 US, 752 OUS))

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.

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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.