Philips X-ray Imaging System Motorized Functions May Fail Due to Component Deterioration
Philips Allura Xper FD20/15 X-ray imaging systems may lose motorized positioning due to internal component deterioration. Manual controls 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: FDA Class II medical device recall due to internal component deterioration affecting motorized functionality. No reported injuries or illnesses; manual positioning controls and X-ray imaging functionality remain operational, limiting operational impact to automated positioning features.
Plain-English summary
The Philips Allura Xper FD20/15 is an interventional X-ray imaging system used in healthcare facilities. The system is being recalled because certain internal components—the CMOS battery, hard disk drive, and/or power supply unit—may deteriorate over time. If this deterioration occurs, the motorized movements that control C-arm and table positioning will become unavailable.
The recall involves 98 systems worldwide, of which 23 are located in the United States. Affected facilities should contact Philips Medical Systems Nederland B.V. for guidance on component inspection, testing, and replacement. Manual positioning controls for the C-arm and table remain functional, as does the X-ray imaging capability.
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
- equipment-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: 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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