Philips Medical Systems Nederland B.V. recalled 98 radiology imaging systems on September 3, 2025. The recall stems from internal component deterioration that may hinder motorized movements. Patients and healthcare providers must stop using the devices immediately.
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 affects Allura Xper FD20/15, Product Code: 722058. The systems include associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. The devices were distributed worldwide, including the United States and 75 other countries.
Deterioration of internal components, including the CMOS battery, hard disk drive, and power supply unit, may lead to loss of motorized functions. Manual movements remain possible, and imaging capabilities are unaffected. The recall classification is Class II.
Stop using the recalled systems immediately. Follow the manufacturer's recall instructions and contact Philips Medical Systems or your healthcare provider for guidance.
For more information, contact Philips Medical Systems Nederland B.V. or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2633-2025.
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