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
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software
ISO 14971 Risk Management (typically with heavy emphasis on software aspect)
IEC 81001-5-1 Cybersecurity Lifecycle
ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits
Being Agile Yet Compliant (AAMI TIR 45)
IEC 29119-1 Software and System Testing
US Classification for Software Devices
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
