Philips Allura Xper FD20 Biplane System Motorized Component Deterioration
Philips Allura Xper FD20 biplane X-ray systems may experience deterioration of internal components, causing loss of motorized movements. Manual movements and imaging functionality 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 FDA Class II medical device recall involves deterioration of internal components affecting motorized functionality. No injuries or illnesses are mentioned in the source documentation, and manual movements and X-ray imaging remain available, supporting a High severity assessment.
Plain-English summary
The Allura Xper FD20 biplane is a medical X-ray imaging system manufactured by Philips Medical Systems Nederland B.V. and used in hospitals and imaging centers worldwide.
Internal components in affected units—including the CMOS battery, hard disk drive, and/or power supply unit—may deteriorate over time. This deterioration can cause the motorized movements of the system (longitudinal, transversal, and rotational movements for ceiling-mounted systems; rotational movements for floor-mounted systems) to become unavailable. The table longitudinal movements and all X-ray imaging functionality remain operational.
This recall affects 268 units (102 in the United States and 166 in other countries). Healthcare facilities with affected systems should contact Philips for support and ensure that manual movement capabilities are verified before clinical use. Imaging functionality continues to operate normally.
The recalled product
- Product
- Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- device-malfunction
- component-degradation
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)722013
- (2) 722008
- UDI-DI: (1) 00884838059061
- (2) N/A
- Serial numbers: (1) 505
- 313
- 34
- 153
- 410
- 360
- 290
- 241
- 404
- 126
- 244
- 106
- 346
- 383
- 461
- 307
Distribution
Distributed nationwide across the United States.
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