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U.S. Department of Health and Human Services

Class 2 Device Recall Clinician Programmer Application (CPA)

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 Class 2 Device Recall Clinician Programmer Application (CPA)see related information
Date Initiated by FirmSeptember 23, 2021
Create DateNovember 04, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0201-2022
Recall Event ID 88761
PMA NumberP960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
ProductClinician Programmer Application (CPA) model A610 Clinician Software Application
Code Information Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactLindsey Dickinson
763-514-2000
Manufacturer Reason
for Recall		A software anomaly may occur with the clinician programmer application.
FDA Determined
Cause 2		Software design
ActionA 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 Commerce3302
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MHY
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