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 Philips Medical Systems, ST80i Stress Test System [Model No.:860343; Software version: A.03.01; HKMD No.: 210470].
According to TGA, when patient demographic information is entered into affected Philips ST80i Stress Test Systems (software version, A.03.01.) and the patient information is saved or exported to a folder, in very rare situations, the demographic information that is displayed is that of the previous patient instead of the current patient, resulting in patient data mismatch.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00140-1.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Jan 2022