Philips Allura Xper FD20/20 X-Ray System: Motorized Movement Malfunction Risk
Philips is recalling 75 Allura Xper FD20/20 X-ray systems worldwide due to potential deterioration of internal components, which may disable motorized movements. Manual movements and imaging capabilities remain functional.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves functional deterioration of motorized system components, but manual alternatives remain available and imaging functionality is unaffected, making this a functional issue rather than a direct safety risk.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 75 units of the Allura Xper FD20/20 X-ray imaging system (Product Code 722038) distributed worldwide, including 26 units in the United States.
The systems may not perform as intended due to deterioration of certain internal components—specifically the CMOS battery, hard disk drive, and/or power supply unit. If this deterioration occurs, motorized movements of the system stand will become unavailable.
Manual movements of the system stand (longitudinal, transversal, and rotational for ceiling-mounted systems; rotational for floor-mounted systems) and table longitudinal movements remain available. X-ray imaging functionality is unaffected.
The recalled product
- Product
- Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- component-deterioration
- system-malfunction
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 Code: 722038
- UDI-DI: 00884838054226
- Serial numbers: 39
- 63
- 42
- 55
- 67
- 99
- 60
- 71
- 115
- 78
- 106
- 118
- 130
- 49
- 119
- 126
- 173
- 37
Distribution
Distributed nationwide across the United States.
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