Philips Medical Systems Nederland B.V. recalled 45 Allura Xper FD20/10 imaging systems on September 3, 2025. The systems may fail due to internal component deterioration, posing a high risk to users. Affected units include 11 in the U.S. and 34 internationally.
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
The recall affects Allura Xper FD20/10 systems, Product Code 722029. This includes models associated with several 510(k) numbers. The systems were distributed worldwide, including 11 units in the U.S.
Deterioration of internal components can lead to a failure in motorized movements of the system. Users can still perform manual movements, but the risk of malfunction poses a high hazard level.
There have been no reported injuries or deaths related to this recall. The potential for malfunction remains a concern for patient safety.
Patients and healthcare providers must stop using the recalled imaging systems immediately. Follow the recall instructions provided by Philips Medical Systems.
Contact Philips Medical Systems Nederland B.V. for further guidance. Visit their website or call for assistance regarding the recall.
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