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FDA (Device enforcement)Recalled 2025-09-03class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K03373

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indon Quantity: 2 units (1 US, 1 OUS) Lot/code info: Product Codes: (1)722022, (2) 722033; UDI-DI: (1) 00884838059078, (2) 00884838054233; Serial numbers: (1) 6, (2) 1;

UPC codes

00884838059078, 00884838054233

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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