Philips Medical Systems Nederland B.V. recalls 75 Allura Xper FD20/20 imaging systems due to potential deterioration of the CMOS battery, hard drive and power supply. Motorized movements could become unavailable while X-ray imaging remains functional. Operators should stop using affected units and follow manufacturer 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 FD20/20 is a dedicated interventional imaging system used in cath labs for X-ray guided procedures.
Deterioration in certain internal parts can stop motorized movements, potentially complicating procedures, while still enabling manual operation and imaging.
This recall is not identified as part of a broader industry pattern.
Immediate use restrictions for facilities with affected units; potential workflow disruption and scheduling impacts.
Manufacturer recall notice and FDA enforcement report linked in the provided source
Refunds or repairs typically coordinated through Philips; no explicit timeline provided in data
Retain recall notices, service reports, serial list
Product: Allura Xper FD20/20; Product Code: 722038. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Quantity: 75 units (26 US, 49 outside US). Distribution: Worldwide. Recall date: 2025-09-03. Status: Active.
No specific incidents or injuries are reported in the provided data.
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