01
Sep
2022

Recall- Potential for Software Anomalies on Transvenous Defibrillators

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

PRODUCT

Programmer/Recorder/Monitor (PRM)

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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