Recall – Clinician programmer application software anomaly

Company: Medtronic Neuromodulation
Date of Enforcement Report: 11/10/2021
Class II

PRODUCT

Clinician Programmer Application (CPA) model A610 Clinician Software Application

Recall Number: Z-0201-2022

REASON

A software anomaly may occur with the clinician programmer application.

RECALLING FIRM/MANUFACTURER

Medtronic Neuromodulation on 9/23/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3302

DISTRIBUTION

U.S. Nationwide and International

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

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