Philips surgical table motorized movement malfunction due to component deterioration
Philips Allura Xper FD10 operating room tables may experience motorized movement failure due to internal component deterioration. Manual positioning and imaging functions remain operational.
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: Class II medical device used in surgical settings where loss of motorized positioning could complicate surgical procedures. This is a risk-of-harm medical device where no injuries have been reported yet, meeting the High severity criterion for risk-of-harm products with injury not yet reported.
Plain-English summary
Philips Medical Systems Nederland B.V. has issued a recall for the Allura Xper FD10 OR Table (product codes 722022 and 722033) due to potential deterioration of internal components including the CMOS battery, hard disk drive, and/or power supply unit.
If component deterioration occurs, the motorized movements of the surgical table will become unavailable. This affects longitudinal, transversal, and rotational movements on ceiling-mounted systems and rotational movements on floor-mounted systems. However, manual positioning remains available for all these movements, and X-ray imaging functionality is not affected.
The recall affects 2 units total (1 in the US and 1 outside the US). The device is distributed worldwide across numerous countries. Affected facilities should contact Philips Medical Systems Nederland B.V. for corrective action options.
Users of affected systems should verify the operational status of motorized table movements and understand that manual positioning alternatives remain available if motorized function is lost.
The recalled product
- Product
- Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- equipment-malfunction
- motorized-function-loss
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 (6)
- Product Codes: (1)722022
- (2) 722033
- UDI-DI: (1) 00884838059078
- (2) 00884838054233
- Serial numbers: (1) 6
- (2) 1
Distribution
Distributed nationwide across the United States.
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