Philips Allura Xper FD10 X-ray Systems Recalled for Component Deterioration
Philips is recalling the Allura Xper FD10 imaging system due to internal component deterioration that can disable motorized movements. Manual controls and X-ray imaging functionality remain available.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported injuries, illnesses, or deaths. While component deterioration in medical equipment warrants attention, core X-ray imaging capabilities and manual positioning controls remain fully functional, making this a precautionary recall rather than an imminent safety threat.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10 interventional imaging system (product codes 722010, 722026, 722003). The recall affects 1,117 units distributed worldwide, including 252 units in the United States.
The recalled systems may experience deterioration of internal components, specifically the CMOS battery, hard disk drive, and/or power supply unit. When this deterioration occurs, motorized movements of the imaging system become unavailable, affecting motorized positioning of the stand and table.
The X-ray imaging functionality and manual control options remain operational. Users can continue to manually adjust the stand (longitudinal, transversal, and rotational movements for ceiling-mounted systems; rotational for floor-mounted systems) and table longitudinal movements. No injuries or illnesses have been reported.
Facilities operating these systems should contact Philips for service or replacement of deteriorated components to restore full motorized functionality. All affected units are identified by serial number or product code listed in the recall notice.
The recalled product
- Product
- Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Imaging System
- Hazard
- component-degradation
- motorized-function-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Codes: (1)722010
- (2) 722026
- (3) 722003
- UDI-DI: (1) 00884838059030
- (2) 00884838054189
- (3) N/A
- Serial numbers: (1) 764
- 177
- 662
- 905
- 480
- 499
- 833
- 787
- 1336
- 839
- 1048
- 343
- 1011
- 917
Distribution
Distributed nationwide across the United States.
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