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U.S. Department of Health and Human Services

Class 2 Device Recall A901 Communication Manager Application

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 Class 2 Device Recall A901 Communication Manager Applicationsee related information
Date Initiated by FirmJune 21, 2023
Date PostedJuly 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2226-2023
Recall Event ID 92530
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductA901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Code Information Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactJeffrey Trauring
763-505-0159
Manufacturer Reason
for Recall		When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
FDA Determined
Cause 2		Under Investigation by firm
ActionOnly one of the two consignees received the notification since one of the consignees independently updated their tablet. On 6/22/2023, the notification dated June 2023 was issued to the consignee via visit by the sales representative. The notification described the issue and provided required actions which included: (1) Update the A901 Comm Manager application to version 1.0.1239 on the clinician programmer (tablet), serial #NPL3011706, using the instructions listed in Appendix A, Updating Clinician Programmer Software; (2) Complete the Customer Confirmation Form enclosed with the letter acknowledging that the consignee has received this information; and (3) Share this notice with all those who need to be aware of the issue within the organization and maintain a copy of it in the records.
Quantity in Commerce2 clinician tablets
DistributionInternational distribution to the countries of Israel and Serbia.
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.
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