27
Dec
2024

FDA Recall: Software Issues in Updated Applications

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0

Company: Medtronic Neuromodulation
Date of Enforcement Report: 12/27/2024
Class II

PRODUCT

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

Recall Number:

Z-0771-2025

REASON:

Software issues were identified in application version 2.x.

RECALLING FIRM/MANUFACTURER:

Medtronic Neuromodulation

VOLUME OF PRODUCT IN COMMERCE:

319 systems

DISTRIBUTION:

Worldwide – US Nationwide 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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