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.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Ingenia Elition X, Ingenia Elition S, SmartPath to Ingenia Elition X, MR 7700 and 'Upgrade to MR 7700' [HKMD No.: 190390].
According to the MHRA, the manufacturer has identified an issue where a specific component failure in the Gradient Coil of the Affected 3T MR Systems 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:
For further information, please visit https://mhra-gov.filecamp.com/s/d/qR5wh5nSnBvVFycR
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Apr 2023