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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 Allura Xper Systems Recalled for Mechanical Failure and Collision Risk

Agency Publication Date: December 12, 2024
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Summary

Approximately 2,782 Philips Allura Xper medical imaging systems (Models R7.6 through R8.1) are being recalled. For systems over 10 years old, internal bolts may break if a Lifetime Extension kit was not installed. This failure can cause the X-ray arm to move erratically or stop moving, potentially colliding with patients or bystanders or requiring additional X-ray exams that expose patients to unnecessary radiation. Philips is initiating this voluntary recall to address these safety risks through inspections and repairs.

Risk

Broken motor and locking bolts can cause unexpected movements of the heavy C-arm or false collision detections. This poses a direct risk of physical injury from mechanical impact and potential radiation overexposure if re-examinations are required due to image quality failures.

What You Should Do

  1. This recall affects Philips Allura Xper FD10 and FD20 systems, including biplane and OR table configurations, sold under model numbers 722010, 722011, 722012, 722013, 722022, 722023, and 722025.
  2. Check your device label for the model number and serial number to determine if it is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately if you observe erratic C-arm movements or image noise.
  4. Contact Philips Medical Systems Nederland B.V. or your local authorized distributor to schedule a mandatory inspection and the installation of the Lifetime Extension (LTE) kit.
  5. Healthcare facilities should follow all instructions provided in the firm's notification letter sent in November 2024.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information about 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 Allura Xper FD10
Variants: R7.6-R8.1
Model / REF:
722010
Serial Numbers (763):
164
272
819
828
33
39
42
43
65
67
69
79
107
119
127
158
160
169
177
190
191
209
213
214
215
218
227
229
239
240
241
252
274
280
285
286
290
296
298
306
308
316
342
343
344
360
364
365
395
411
UDI:
00884838054189
00884838059030

Units over 10 years of life requiring LTE kits.

Product: Philips Allura Xper FD10/10
Variants: R7.6-R8.1
Model / REF:
722011
Serial Numbers (204):
157
83
308
95
107
34
59
23
319
49
170
137
173
101
84
155
133
234
345
124
332
102
270
177
132
325
15
76
79
17
87
237
255
50
171
168
22
275
344
324
140
163
172
103
82
154
215
40
69
272

Affected units older than 10 years without LTE kit installation.

Product: Philips Allura Xper FD20
Variants: R7.6-R8.1
Model / REF:
722012
Serial Numbers (1392):
1356
191
351
583
655
796
950
1117
1001
1673
1712
585
517
1545
70
1715
504
757
935
1250
1613
2006
1733
1734
2201
1922
741
92
1034
1359
1848
865
1908
1166
1113
1659
494
335
1804
1473
1408
1401
1588
576
595
590
2302
1279
2151
481
UDI:
00884838059054

Affected units older than 10 years.

Product: Philips Allura Xper FD20 Biplane
Variants: R7.6-R8.1
Model / REF:
722013
Serial Numbers (325):
505
217
313
492
34
153
410
360
290
74
83
580
160
404
126
244
106
346
461
307
1
442
435
293
297
46
289
638
342
69
267
214
402
113
86
603
82
149
424
140
254
255
266
475
518
519
303
194
115
150

Biplane system units over 10 years old.

Product: Philips Allura Xper FD10 OR Table
Variants: R7.6-R8.1
Model / REF:
722022
Serial Numbers:
6

OR table component.

Product: Philips Allura Xper FD20 OR Table
Variants: R7.6-R8.1
Model / REF:
722023
Serial Numbers (94):
27
116
12
175
98
35
72
142
46
64
110
49
124
66
117
109
42
138
82
83
127
75
118
41
33
146
121
119
70
112
47
137
25
114
105
90
107
74
5
9
4
14
13
16
132
88
73
99
38
141

OR table component.

Product: Philips Allura Xper FD20 Biplane OR Table
Variants: R7.6-R8.1
Model / REF:
722025
Serial Numbers:
3
2
6

OR table component.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95713
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Authorized Philips medical equipment distributors; Direct hospital sales
Manufactured In: Netherlands
Units Affected: 2,782 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.