Philips Medical Systems Nederland B.V. recall involves 46 Allura CV20 imaging systems distributed worldwide. The devices may fail to perform due to deterioration of internal components including the CMOS battery, hard disk drive and power supply unit. If this occurs, motorized movements could become unavailable while imaging remains functional. The recall alerts patients and healthcare providers;停
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 CV20 is a medical imaging system used in radiology to perform X-ray scans. It supports both motorized and manual adjustments depending on configuration.
Internal component deterioration could cause loss of motorized movement, potentially impacting workflow but imaging remains possible.
This recall is part of ongoing monitoring of medical imaging systems for reliability of internal power and control components.
Hospitals may experience downtime in automated positioning, potentially affecting throughput and staff workflow.
Recall letter and FDA enforcement report Z-2635-2025; product packaging and device label
Recalls initiated in 2025 with ongoing guidance; replacement timelines depend on manufacturer arrangements
Keep recall letter, serial list, service agreements, and communications with Philips as records
Product: Allura CV20. Product Code: 722031. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Quantity: 46 units (OUS only). Distribution: Worldwide, including US nationwide and numerous countries listed. Status: Active as of 2025-10-01.
No specific injuries or incidents are detailed in the provided document.
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