Recall- Software Anomalies with Transvenous Defibrillators

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

Worldwide Distribution

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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