Recall – INS software anomaly results in failure to connect

Company: Medtronic Neuromodulation
Date of Enforcement Report: 12/23/2020
Class II

PRODUCT

Percept PC Implantable Neurostimulator (INS) – Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

Recall Number: Z-0612-2021

REASON

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

RECALLING FIRM/MANUFACTURER

Medtronic Neuromodulation on 11/19/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

12 devices

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts 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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