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

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.