Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration
Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and 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 an FDA Class II recall of a medical device. Although motorized movement functionality may be lost, manual movements and imaging functionality remain available, and the source explicitly does not report any illnesses or injuries, making this a precautionary or degraded-function scenario rather than a direct safety hazard.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20/15 X-ray system (Product Code 722058) due to deterioration of certain internal components, including the CMOS battery, hard disk drive, and/or power supply unit.
If deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the 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 recall affects 98 units worldwide, including 23 in the US and 75 outside the US, distributed across numerous countries. Users of affected systems should consult Philips for further guidance and remediation options.
The recalled product
- Product
- Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- component-deterioration
- motorized-movement-failure
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: 722058
- UDI-DI: 00884838059115
- Serial numbers: 249
- 22
- 71
- 85
- 138
- 24
- 167
- 168
- 129
- 149
- 259
- 134
- 38
- 56
- 61
- 99
- 59
- 109
Distribution
Distributed nationwide across the United States.
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