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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 X-ray Imaging Systems Recalled for Risk of Imaging Function Loss

Agency Publication Date: July 29, 2025
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Summary

Philips Medical Systems Nederland B.V. has recalled 4,508 Philips Allura R8.2.x Systems, including various Allura Xper models and specialized OR tables. The recall is due to a software issue that can cause a temporary loss of X-ray imaging functionality during medical procedures. If the imaging fails while a procedure is underway, it could result in delays or complications for patients. Philips has initiated this voluntary recall through a notification letter to affected clinical facilities to address the software defect.

Risk

The software issue may cause the system to stop providing X-ray images unexpectedly. During diagnostic or surgical procedures, this loss of visibility can force clinicians to pause, reset the system, or potentially switch to alternative methods, increasing procedural risks and patient complications.

What You Should Do

  1. This recall involves Philips Allura R8.2.x Systems with software version R8.2.x, specifically Allura Xper models FD10, FD20, and specialized OR tables. Check the model number and software version displayed on your system's label or interface. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled systems immediately if you experience imaging failure or if the software version is R8.2.x.
  3. Contact Philips Medical Systems or your authorized distributor to arrange for a software correction, system update, or further technical guidance.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

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: Software Version R8.2.x
Model / REF:
722026
Serial Numbers (1077):
765
156
253
287
825
394
713
465
74
462
192
191
522
204
155
1132
967
205
1246
122
259
185
618
531
855
235
805
725
832
368
646
653
663
965
258
602
908
959
221
1129
973
664
778
109
110
116
512
115
284
389
UDI:
00884838054189

Model Number: 722026.

Product: Philips Allura Xper FD10/10
Variants: Software Version R8.2.x
Model / REF:
722027
Serial Numbers (283):
203
335
123
133
134
284
280
32
183
222
169
106
107
234
42
101
265
306
307
246
209
267
153
40
332
156
112
305
1
104
263
342
71
255
351
175
298
120
174
116
240
241
216
230
29
50
288
56
41
152
UDI:
00884838054196

Model Number: 722027.

Product: Philips Allura Xper FD20
Variants: Software Version R8.2.x
Model / REF:
722028
Serial Numbers (2420):
1811
819
1598
316
1946
945
541
565
647
674
864
1041
710
880
946
949
961
447
236
237
238
356
696
1188
1189
1098
793
656
618
313
329
274
1214
1846
1978
1649
1256
1024
2192
904
242
284
1397
1957
167
207
208
526
1820
1756
UDI:
00884838054202

Model Number: 722028.

Product: Philips Allura Xper FD20/10
Variants: Software Version R8.2.x
Model / REF:
722029
Serial Numbers (91):
71
91
7
94
62
88
36
97
21
100
30
63
22
60
129
95
126
110
56
55
57
31
115
119
87
93
6
24
32
39
69
34
14
122
127
45
48
37
23
44
40
66
38
98
75
35
89
82
61
53
UDI:
00884838054219

Model Number: 722029.

Product: Philips Allura Xper FD10 OR Table
Variants: Software Version R8.2.x
Model / REF:
722033
Serial Numbers:
1
UDI:
00884838054233

Model Number: 722033.

Product: Philips Allura Xper FD20 OR Table
Variants: Software Version R8.2.x
Model / REF:
722035
Serial Numbers (197):
243
123
38
85
24
101
117
212
21
177
172
183
252
236
88
57
143
125
145
161
244
119
100
165
47
126
127
52
247
131
147
124
89
169
46
242
245
246
74
30
192
59
60
196
216
187
121
34
222
72
UDI:
00884838054240

Model Number: 722035.

Product: Philips Allura Xper FD20/20
Variants: Software Version R8.2.x
Model / REF:
722038
Serial Numbers (117):
39
63
42
55
67
99
60
71
141
115
7
78
108
106
167
118
130
49
119
126
173
37
38
48
62
35
137
120
41
131
157
96
70
46
102
153
155
171
172
163
129
161
122
156
121
113
169
160
152
162
UDI:
00884838054226

Model Number: 722038.

Product: Philips Allura Xper FD20/20 OR Table
Variants: Software Version R8.2.x
Model / REF:
722039
Serial Numbers:
3
8
6
5
4
2
UDI:
00884838054271

Model Number: 722039.

Product: Philips Allura Xper FD20/15
Variants: Software Version R8.2.x
Model / REF:
722058
Serial Numbers (306):
172
337
178
249
22
202
279
254
285
71
186
82
85
162
138
24
365
203
167
146
168
304
288
200
123
129
149
259
4
197
134
38
290
171
56
264
238
199
61
156
99
65
59
109
100
305
319
215
278
124
UDI:
00884838059115

Model Number: 722058.

Product: Philips Allura Xper FD20/15 OR Table
Variants: Software Version R8.2.x
Model / REF:
722059
Serial Numbers:
7
33
8
40
41
2
37
38
35
UDI:
00884838059122

Model Number: 722059.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97155
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Hospitals; Surgical Centers; Medical Imaging Facilities; Authorized Medical Device Distributors
Manufactured In: Netherlands
Units Affected: 4,508 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.