Recall: Software Anomalies in CP App Messages

Company: Medtronic Neuromodulation
Date of Enforcement Report: 01/06/2023
Class II

PRODUCT

Devices

Recall Number:

Z-0911-2023

REASON

Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303”

RECALLING FIRM/MANUFACTURER

Medtronic Neuromodulation

VOLUME OF PRODUCT IN COMMERCE

440 units

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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