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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 Firm September 23, 2021
Create Date November 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-0201-2022
Recall Event ID 88761
PMA Number P960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Clinician 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
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Lindsey Dickinson
763-514-2000
Manufacturer Reason
for Recall		 A software anomaly may occur with the clinician programmer application.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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