Z-0201-2022 Class II Ongoing
FDA device recall Z-0201-2022 was initiated by Medtronic Neuromodulation on Sep 23, 2021 and is designated Class II. Reason for recall: A software anomaly may occur with the clinician programmer application. The recall status is ongoing. Affected quantity: 3302.
Recall details
- Product Type
- Devices
- Report Date
- Nov 10, 2021
- Initiation Date
- Sep 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3302
Product description
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Reason for recall
A software anomaly may occur with the clinician programmer application.
Distribution pattern
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.
Code information
Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0201-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026