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.
TGA has issued a medical device safety alert concerning all GE Healthcare MRI systems with superconducting magnets.
According to TGA, the manufacturer is advising that the GEHC Magnetic Resonance (“MR”) systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet quench, potentially depriving the room of oxygen. The manufacturer is advising users that they can continue to use the system as normal. Users are asked to follow the instructions as listed in the customer letter.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00080-1
Regarding the preliminary information provided by the Local Responsible Person, HKMD No.: 170029 was involved in the alert. The list of involved HKMD No. will be updated once available. If you are in possession of GE Healthcare MRI systems with superconducting magnets or have any problems, please contact your supplier for necessary actions and advices.
Posted on 14 Jan 2022