Philips Medical Systems Nederland B.V. recalls 2 Allura Xper FD10 OR Tables worldwide. The devices may fail to perform motorized movements due to deterioration of internal components. Healthcare providers should stop using the devices and contact Philips for instructions.
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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The Allura Xper FD10 OR Table is a fluoroscopy-assisted operating room table used in surgical settings. It supports patient positioning and imaging workflows during procedures.
Deterioration of internal components may disable motorized movements, potentially hindering patient positioning during surgery while imaging remains possible.
This recall is not indicated as part of a broader industry pattern in the provided data.
Hospitals and clinicians could experience delays or gridlock during procedures if motorized adjustments fail. The action required is to halt use until replacement or service is provided.
Recall notices from Philips and FDA enforcement pages; device labels and hospital procurement records
Remediation timelines vary; 4-8 weeks is a common range for recall processing and replacement arrangements
Document all communications with Philips, retain the recall letter, keep service orders and replacement documentation
Product: Allura Xper FD10 OR Table Model numbers: 722022, 722033, 00884838059078, 00884838054233 Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949 Sold worldwide: Worldwide distribution (US and numerous countries listed) Recall date: 2025-09-03 Status: Active Quantity: 2 units (1 US, 1 outside US)
No injuries or incidents have been reported.
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