Philips Medical Systems recalled 286 Allura Xper FD10/10 imaging systems on September 3, 2025. The recall affects models 722011, 722027, and 722005 due to potential failure of internal components. This malfunction could inhibit motorized movements, posing risks to patient safety.
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 recall involves Allura Xper FD10/10 imaging systems with product codes 722011, 722027, and 722005. The devices were distributed worldwide, including 67 units in the U.S. and 219 units internationally.
The deterioration of internal components, such as the CMOS battery, hard disk drive, and power supply unit, may cause systems to fail. While imaging capabilities remain intact, motorized movements of the system will become unavailable.
No specific incidents of injury have been reported related to this recall. However, the potential for operational failure presents a high risk to patient safety.
Stop using the affected devices immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions and to follow the recall process.
For more information, call Philips at 1-800-XXX-XXXX or visit their website at www.philips.com. Additional recall details can be found at the FDA website.
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