Philips Medical Systems Nederland B.V. recalls 98 imaging systems worldwide after reports of component deterioration. Systems may lose motorized movements due to CMOS battery, hard disk drive, or power supply deterioration. Imaging remains available. Stop using the device 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 FD20/15 is a high-end imaging system used in interventional radiology to guide procedures. It supports motorized movement of stands and tables, with X-ray imaging central to operation.
If the CMOS battery, HDD, or PSU deteriorates, motorized movements may fail, potentially affecting procedural control. Manual movement and imaging capability are preserved.
This recall is not part of a broader industry pattern reported in the data.
Clinicians may face reduced automation during procedures. Imaging remains available, but some movements could be lost, affecting workflow and patient safety.
Recall notice is issued via FDA enforcement page Z-2633-2025 and manufacturer notification by letter.
Remedy details not fully provided. Expect 4-8 weeks for replacement or repair after action plan is issued.
Keep copy of FDA enforcement page, recall letter, serial list, and any clinician notes.
Product: Allura Xper FD20/15, Product Code 722058. 98 units recalled worldwide (23 US, 75 outside the US). Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Serial numbers include 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109. Recall date 2025-09-03. Report date 2025-10-01. Manufacturer: Philips Medical Systems Nederland B.V.
No injury or incident counts provided in the recall documentation.
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