Safety Alerts

Safety Alerts

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 Safety Alert: Philips Medical Systems, ST80i Stress Test System

19 Jan 2022

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.

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If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 Jan 2022