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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Boston Scientific Corporation Zoom Programming System [Model 2892 Software application on Model 3120 Zoom Programmer] [HKMD No.: 130336].
According to the TGA, starting on 10 January 2024, the clock parameter used by the Model 2892 software application on the Model 3120 ZOOM programmer will display certain diagnostic dates incorrectly, with a year in the 1990s. The Model 2892 software application supports the remaining ALTRUA, INSIGNIA and family of pacemakers that were distributed between October 2001 and August 2018. Affected diagnostic dates that will display incorrectly on or after 10 January 2024, include date of last battery test, last programmed date, last interrogation date, last reset counter/histograms, and the dates of follow-up tests such as intrinsic amplitude, pacing impedance, and pacing threshold tests. The replacement indicator dates and date of events in the arrhythmia logbook are not affected and display correctly. There is no impact to the performance of the pacemaker, actual longevity remaining of the pacemaker, nor battery gas gauge display.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-01030-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Dec 2023