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 its Ingenia Elition X, Ingenia Elition S, SmartPath to Ingenia Elition X, MR 7700 and ‘Upgrade to MR 7700’ [Multiple serial number] [HKMD No.: 190390].
The manufacturer has identified an issue where a specific component failure in the Gradient Coil of where the affected 3T MR Systems identified may act as a heat source, with a potential to produce smoke and/or fire.
If the component failure occurs, the user may observe the following:
The manufacturer has received two complaints of fire associated with the Ingenia Elition MR system. In both cases there was no report of injury or serious harm, however damage to property has occurred. If smoke or a fire were to occur, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
If smoke or a fire were to occur, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Nov 2022