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