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 Achieva 1.5T, Achieva 1.5T Conversion, Ingenia 1.5T CX, Intera 1.5T, Intera 1.5T Power/Pulsar, SmartPath to dStream for 1.5T [Product Number (REF): 781105, 781195, 781295, 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781260, 782112; Multiple serial numbers] [HKMD No.: 110311, 190186].
The manufacturer has identified an issue where a specific component failure in the Gradient Coil of the affected 1.5T MR Systems listed in the Field Safety Notice (FSN) 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:
According to the manufacturer, if smoke or a fire occurs, 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.
Affected users should follow the action listed on the FSN issued by the manufacturer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 Nov 2023