Philips Medical Systems Netherlands B.V. recalls 1,117 Allura Xper FD10 imaging systems worldwide, including 252 units in the United States. The defect involves deterioration of internal components such as the CMOS battery, hard disk drive and power supply unit, which can disable motorized movements. Hospitals should stop using the devices and follow the manufacturer recall 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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Allura Xper FD10 is an interventional imaging system used for fluoroscopy in clinical procedures. The recall affects systems that rely on motorized movement to position components during imaging.
If internal components deteriorate, motorized positioning may become unavailable, which could complicate procedures. Manual movements remain available, and imaging functionality is preserved.
This recall is not described as part of a broader industry pattern.
Hospitals must stop using affected devices and coordinate with the manufacturer for replacement or remediation. The impact includes potential procedure delays and equipment downtime.
FDA enforcement page on enforce_rpt-Product-Tabs.cfm?recall_number=Z-2623-2025 and the manufacturer notice.
Recall processes typically take weeks to months. The notice does not specify replacement timelines.
Retain the recall letter, maintain device serials, keep service records, and log communications with the manufacturer and hospital administration.
Model numbers: 722010, 722026, 722003. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Sold worldwide, including 252 US units and 865 outside the US. Sold date and price information not provided.
No injuries or incidents have been reported.
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