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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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