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 manufacturer, Philips, has issued a medical device safety alert concerning Ingenia LS MR Systems (Model Number:781068) and Prodiva 1.5T (Model number 781069, 781070) [HKMD No.:180361].
The manufacturer is informing users that it has identified an issue where a loose screw on the tabletop belt wheel of Prodiva 1.5T and Ingenia LS MR systems may impede horizontal movement for both motorized and manual modes.
If the tabletop’s horizontal movement is obstructed before the scan begins, the scan cannot be started which may lead to a delay in diagnosis.
If the tabletop’s horizontal movement is obstructed during a scan, the operator will be not able to release the tabletop which may lead to：
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Mar 2023