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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 X-Ray Systems Recalled for Missing Air Baffle

Agency Publication Date: September 3, 2025
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Summary

Philips Medical Systems Nederland B.V. is recalling 192 units of its Allura Xper Series Interventional Fluoroscopic X-Ray Systems, including multiple FD10 and FD20 models. The recall was initiated because a specific component, an air baffle, may be missing in some Nehalem FlexVision-2 PCs that are integral to these systems. No injuries have been reported at this time, but the manufacturer is notifying customers via letter to arrange for corrections.

Risk

The missing air baffle can lead to internal PC components overheating. This overheating may cause the X-ray system to fail or shut down unexpectedly during a medical procedure, potentially delaying critical diagnosis or treatment for patients.

What You Should Do

  1. This recall affects Philips Allura Xper Series Interventional Fluoroscopic X-Ray Systems, specifically models 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722023, 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
  2. To identify if your unit is affected, check the model number and serial number on the device identification label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to prevent system failure during active patient procedures.
  4. Contact Philips Medical Systems Nederland B.V. or your local distributor to coordinate the inspection and repair of your system to ensure the required air baffle is installed.
  5. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional assistance.

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
Model / REF:
722003
Serial Numbers:
292
314
1077
464

Part of the Allura Xper series using Nehalem FlexVision-2 PCs.

Product: Philips Allura Xper FD10/10
Model / REF:
722005
Serial Numbers:
54
Product: Philips Allura Xper FD20
Model / REF:
722006
Serial Numbers:
2126
2200
1560
1921
1724
1219
Product: Philips Allura Xper FD20 Biplane
Model / REF:
722008
Serial Numbers:
516
142
434
418
480
Product: Philips Allura Xper FD10
Model / REF:
722010
Serial Numbers:
33
968
763
215
1425
1126
818
1028
1043
608
907
50
1390
706
900
1439
1152
165
62
1031
1088
741
840
413
UDI:
00884838059030
Product: Philips Allura Xper FD10/10
Model / REF:
722011
Serial Numbers:
308
344
243
266
231
286
369
378
259
333
UDI:
00884838059047
Product: Philips Allura Xper FD20
Model / REF:
722012
Serial Numbers:
2898
2896
1594
1249
2057
2135
2857
792
2841
1334
1550
2868
2912
1094
2282
1681
1332
2032
2076
176
835
626
1320
1439
1667
UDI:
00884838059054
Product: Philips Allura Xper FD20 Biplane
Model / REF:
722013
Serial Numbers:
115
575
272
632
378
608
412
353
595
355
403
UDI:
00884838059061
Product: Philips Allura Xper FD20 OR Table
Model / REF:
722023
Serial Numbers:
128
83
86
134
87
UDI:
00884838059085
Product: Philips Allura Xper FD10
Model / REF:
722026
Serial Numbers:
233
561
942
368
826
1115
539
159
598
365
528
603
263
792
783
679
680
406
388
302
659
736
1022
22
506
120
526
UDI:
00884838054189
Product: Philips Allura Xper FD10/10
Model / REF:
722027
Serial Numbers:
106
127
78
204
113
82
66
119
UDI:
00884838054196
Product: Philips Allura Xper FD20
Model / REF:
722028
Serial Numbers:
668
265
1154
180
880
274
172
1111
806
451
236
887
874
1266
1499
1514
1457
908
1292
247
944
951
1390
1662
415
105
1675
348
1562
1029
51
941
403
427
659
935
1225
1165
1621
725
723
1559
753
883
UDI:
00884838054202
Product: Philips Allura Xper FD20/10
Model / REF:
722029
Serial Numbers:
69
58
UDI:
00884838054219
Product: Philips Allura Xper FD20 OR Table
Model / REF:
722035
Serial Numbers:
187
125
40
108
163
26
75
173
190
103
UDI:
00884838054240
Product: Philips Allura Xper FD20/20
Model / REF:
722038
Serial Numbers:
63
UDI:
00884838054226
Product: Philips Allura Xper FD20/15
Model / REF:
722058
Serial Numbers:
238
161
84
39
133
244
193
187
102
UDI:
00884838059115

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97359
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Philips direct sales; Authorized medical device distributors
Manufactured In: Netherlands
Units Affected: 192 untis
Distributed To: Alabama, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia

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.