Philips Allura Xper FD20 OR Table Motorized Movements May Fail
Philips Allura Xper FD20 operating room tables may lose motorized movement capability 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 is an FDA Class II recall with no reported injuries or illnesses. While loss of motorized movement in surgical equipment could affect patient care, manual positioning and imaging remain available. The recall addresses a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Philips Allura Xper FD20 OR Table is a motorized surgical positioning system used in operating rooms. The recall affects 174 units distributed worldwide, including 45 units in the United States.
Certain internal components—including the CMOS battery, hard disk drive, and power supply unit—may deteriorate over time. This deterioration can cause the motorized movements of the system to become unavailable.
Manual movements (longitudinal, transversal, and rotational for ceiling-mounted systems; rotational for floor-mounted systems) and imaging functionality remain available. The loss of motorized positioning may affect surgical workflow and operating efficiency.
Healthcare facilities using affected units should contact Philips Medical Systems for service information. The affected product codes are 722023, 722035, and 722015.
The recalled product
- Product
- Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- component-failure
- motorized-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)722023
- (2) 722035
- (3) 722015
- UDI-DI: (1) 00884838059085
- (2) 00884838054240
- (3) N/A
- Serial numbers: (1) 27
- 116
- 12
- 175
- 98
- 35
- 142
- 179
- 46
- 64
- 110
- 124
- 66
- 117
Distribution
Distributed nationwide across the United States.
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