FDA recall Z-0201-2022

Product

Clinician Programmer Application (CPA) model A610 Clinician Software Application

Reason for recall

A software anomaly may occur with the clinician programmer application.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.

Key facts

Status

Ongoing

Initiation date

2021-09-23

Report date

2021-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2022