Recalls / —
—#189466
Product
Clinician Programmer Application (CPA) model A610 Clinician Software Application
- FDA product code
- MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P960009
- Affected lot / code info
- Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081
Why it was recalled
A software anomaly may occur with the clinician programmer application.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- 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.
Timeline
- Recall initiated
- 2021-09-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.