Philips Medical Systems Nederland B.V. recalled 75 Allura Xper FD20/20 imaging systems on September 3, 2025. The recall affects systems due to internal component deterioration, which can hinder motorized movements. All users must stop using the device immediately and follow manufacturer instructions for safe handling.
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 recalled Allura Xper FD20/20 imaging systems have product code 722038. They are associated with several 510(k) numbers including K102005 and K130842. The systems were distributed worldwide, with 26 units in the U.S. and 49 units internationally.
Deterioration of internal components such as the CMOS battery and hard disk drive can prevent motorized movements of the imaging system. Manual movements remain operable, and imaging functionality stays intact. This presents a high-risk hazard for healthcare providers and patients.
There have been no reported incidents of injury or death associated with this recall. However, the malfunction of the system may pose risks in clinical settings.
Users should immediately stop using the Allura Xper FD20/20 system. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions on how to proceed. Follow the recall instructions provided by the manufacturer.
For assistance, contact Philips Medical Systems Nederland B.V. at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2630-2025.
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