Philips Medical Systems Nederland B.V. recalled 29 Zenition 50 interventional fluoroscopic x-ray systems distributed in 14 countries. The defect is corrosion of the IITV control board that may cause loss of imaging functionality or poor image quality. Healthcare providers and patients should stop using the device and follow manufacturer instructions for recall remediation.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
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 Zenition 50 is an interventional fluoroscopic x-ray system used in complex diagnostic and therapeutic procedures.
Corrosion on the IITV control board can degrade image quality, potentially affecting procedural accuracy and patient safety.
This recall is not identified as part of a broader industry-wide pattern in the provided data.
The recall directly affects imaging performance critical to interventional radiology procedures, potentially impacting treatment timelines if remediation is delayed.
Manufacturer recall notice and FDA enforcement page linked in the source
Remediation timelines are determined by Philips; hospitals may implement temporary imaging protocols as needed
Keep a record of recall notices, communications, and remediation actions with dates
Brand: Philips Medical Systems Nederland B.V. Product: Zenition 50 Interventional fluoroscopic x-ray system. Product Number (REF): 718096. UDI-DI: 00884838091535. Quantity: 29 units. Distribution: US states of Missouri and Texas; international distribution to Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, Uzbekistan. Status: Active recall as of 2025-10-29.
No specific incidents or injuries are documented in the provided recall notice.
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