Philips Allura Xper FD10/10 X-Ray System Motorized Movement Failure Recall
Philips Allura Xper FD10/10 X-ray systems may lose motorized movement capability due to deterioration of internal components including the CMOS battery, hard disk drive, or power supply unit. Imaging and manual movements 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: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths. The hazard involves partial loss of motorized functionality with manual alternatives and core imaging functionality remaining operational, characteristic of a moderate precautionary device recall.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10/10 (Product Codes 722011, 722027, and 722005) worldwide due to potential deterioration of 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. Affected motorized functions include longitudinal, transversal, and rotational movements of ceiling-mounted systems, as well as rotational movements of floor-mounted systems. However, manual movements of the stand and table, and X-ray imaging functionality remain available.
286 units have been distributed globally, including 67 units in the US and 219 units outside the US. Facilities using affected systems should contact Philips Medical Systems for guidance on addressing this issue.
The recalled product
- Product
- Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; 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 Codes: (1)722011
- (2) 722027
- (3) 722005
- UDI-DI: (1) 00884838059047
- (2) 00884838054196
- (3) N/A
- Serial numbers: (1) 157
- 268
- 95
- 107
- 59
- 319
- 49
- 170
- 173
- 101
- 84
- 155
- 133
- 234
Distribution
Distributed nationwide across the United States.
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