Philips Medical Systems recalled 2,114 Allura Xper FD20 imaging systems on September 3, 2025. The systems may fail due to internal component deterioration, risking loss of motorized functionality. This recall affects 791 units in the U.S. and 1,323 globally.
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 recalled product codes include 722012, 722028, and 722006. These systems were distributed worldwide, including the U.S. and countries such as Canada, Germany, and Australia. No price information is available.
The imaging systems may not perform as intended if internal components, such as the CMOS battery or power supply unit, deteriorate. This can lead to loss of motorized movements, although manual movements and imaging capabilities will remain functional.
No specific injuries or incidents have been reported connected to this recall. The risk level is classified as high due to potential operational failures.
Healthcare providers and patients should stop using the affected devices immediately. Contact Philips Medical Systems for further instructions on the recall process.
For more information, contact Philips Medical Systems Nederland B.V. or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2626-2025.
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