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Safety Alerts and Communications

Safety Alerts

Safety Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.

Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Allura Xper R7.6- R8.1 systems

19 Nov 2024

Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its Allura Xper R7.6- R8.1 systems [Product Name: Allura Xper FD10, Allura Xper FD10 OR Table, Allura Xper FD10/10, Allura Xper FD20, Allura Xper FD20 OR Table, Allura Xper FD20 Biplane, Allura Xper FD20 Biplane OR Table; Model number: 722010, 722022, 722011, 722012, 722023, 722013, 722025] [HKMD No.: 100206, 110046, 110047 and 110048].

The manufacturer has identified that delay of installation of the Lifetime Extension (LTE) kit in Allura Xper R7.6-R8.1 systems may lead to a broken propeller motor clamping bolt and a broken X-ray tube locking bolt.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 Nov 2024

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