Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01030-1
Product Name/Description	Zoom Programming System Model 2892 Software application on Model 3120 Zoom Programmer ARTG 123599 (Boston Scientific Pty Ltd - ZOOM LATITUDE Programming System - Pacemaker programmer)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/12/2023
Responsible Entity	Boston Scientific Pty Ltd
Reason/Issue	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.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers are to follow the instructions in the customer letter (supplied to affected customers by Boston Scientific). When using the Model 2892 software application on the Model 3120 ZOOM programmer, if a date includes a year in the 1990s - Determine a precise date by interrogating an ALTRUA, INSIGNIA pacemaker with a Model 3300 LATITUDE programmer: or - Determine an approximate date (within a two-day range) using the table in Appendix A. Boston Scientific does not recommend prophylactic replacement of pacemakers due to incorrect dates.
Contact Information	02 8063 8340 - Boston Scientific