Medical imaging system recalled due to component deterioration affecting motorized positioning
Philips Allura Xper FD10/10 X-ray systems may lose motorized positioning due to internal component deterioration. Manual positioning and imaging functions remain available.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II device recall involves potential loss of motorized positioning in a medical imaging system with no reported illnesses or injuries. It represents a risk-of-harm product where injury has not yet been reported, as loss of motorized functionality could impact clinical procedures, though manual positioning and critical imaging functions remain available.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10/10 X-ray imaging system due to potential deterioration of internal components, including the CMOS battery, hard disk drive, and power supply unit. If deterioration occurs, motorized movements of the system may become unavailable. These movements include longitudinal, transversal, and rotational positioning for ceiling-mounted systems, and rotational positioning for floor-mounted systems. Manual positioning remains available, and X-ray imaging functionality is unaffected by the component deterioration.
The recall encompasses 286 units distributed worldwide: 67 in the United States and 219 units internationally across numerous countries. The product is classified as a Class II medical device by the FDA.
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
- motorized-positioning-failure
- device-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 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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