X-ray imaging system motorized positioning may fail due to component deterioration
Allura Xper FD20/10 X-ray imaging systems may lose motorized positioning due to internal component deterioration. Manual operation and imaging 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, injuries, or deaths. The hazard is potential component deterioration causing loss of motorized positioning, but manual operation and imaging functionality remain fully available. This is a functional limitation, not an active safety incident.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20/10 X-ray imaging system (Product Code 722029) due to potential deterioration of internal components—specifically the CMOS battery, hard disk drive, and/or power supply unit. If deterioration occurs, motorized movements of the system will become unavailable.
The recall involves 45 units with worldwide distribution, including 11 units in the United States and 34 units internationally. Affected serial numbers have been identified.
If component deterioration occurs, motorized movements of the gantry (longitudinal, transversal, and rotational for ceiling-mounted systems; rotational for floor-mounted systems) and motorized table movements will be unavailable. However, manual positioning of the stand and table remains available, and X-ray imaging functionality is not affected.
Facility operators should contact Philips to determine if their systems are affected and to arrange for inspection, repair, or replacement.
The recalled product
- Product
- Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — X-ray System
- Hazard
- component-deterioration
- motorized-equipment-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: 722029
- UDI-DI: 00884838054219
- Serial numbers: 71
- 7
- 62
- 36
- 21
- 30
- 63
- 129
- 56
- 57
- 31
- 24
- 32
- 39
- 69
- 34
- 45
- 37
Distribution
Distributed nationwide across the United States.
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