Z-0201-2022Class II

Clinician Programmer Application (CPA) model A610 Clinician Software Application

Name: Z-0201-2022 Clinician Programmer Application (CPA) model A610 Clinician Software Application
Creator: Medtronic Neuromodulation
Published: 2021-09-23
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2021-09-23 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Clinician Programmer Application (CPA) model A610 Clinician Software Application on 2021-09-23. FDA classified it as Class II and gives the reason as "A software anomaly may occur with the clinician programmer application". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0201-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-23
Posted: 2021-11-04
Recalling firm: Medtronic Neuromodulation
Product: Clinician Programmer Application (CPA) model A610 Clinician Software Application
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: A software anomaly may occur with the clinician programmer application.
Root cause tag: software
FDA root cause: Software design
Action: A customer letter was distributed to impacted customers beginning September 16, 2021. Customers are asked to contact their Medtronic representative or Medtronic Technical Services at 1-800-707-0933 to troubleshoot should they experience the software anomaly issue.
Quantity in commerce: 3302
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.
Product codes and lots: Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0201-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0201-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-04

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)