Recall Z-0201-2022 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Clinician Programmer Application (CPA) model A610 Clinician Software Application
| Date | Sep 23, 2021 |
| Status | Open, Classified |
| Reason | A software anomaly may occur with the clinician programmer application. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.