Philips Medical Systems Nederland B.V. recalled 268 Allura Xper FD20 Biplane imaging systems worldwide, including 102 in the United States. The recall cites deterioration of internal components that could disable motorized movements. Hospitals should stop using the devices immediately and follow the manufacturer’s 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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The Allura Xper FD20 is a biplane interventional X-ray imaging system used in catheter-based procedures. Patients typically undergo imaging-guided interventions in hospital settings. The recall concerns internal components that may degrade over time.
If the CMOS battery, HDD, or PSU deteriorate, motorized movements could fail during use. This could disrupt procedures, though manual movements and imaging remain available.
This recall is not described as part of a broader industry pattern.
Hospitals may experience procedure delays or mechanical interruptions. The issue requires immediate corrective action to ensure patient safety and procedural continuity.
Serial numbers and date codes are typically on the device label and in service manuals; follow Philips recall communications for exact identifiers.
Immediate action required. Replacement or repair arrangements will be scheduled by Philips; timelines vary by facility and kit availability.
Keep copy of recall notice, letters, service tickets, and correspondence with Philips. Document all steps taken and any procedural changes.
Model numbers: 722013, 722008. Sold worldwide, including 102 units in the United States and 166 outside the U.S. Recall date: 2025-09-03. Distributor/manufacturer: Philips Medical Systems Nederland B.V. (Philips). Price: Not disclosed.
No injuries or incidents have been reported.
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