Company: Boston Scientific Corporation
Date of Enforcement Report: 9/1/2022
Class II

PRODUCT

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.

Recall Number:

Z-1669-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Boston Scientific Corporation

VOLUME OF PRODUCT IN COMMERCE

17,172 units in total

DISTRIBUTION