Company: Boston Scientific Corporation
Date of Enforcement Report: 9/1/2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Boston Scientific Corporation
VOLUME OF PRODUCT IN COMMERCE
17,172 units in total