BEUDAMED
    FDA Recall Open, Classified

    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

    Recall: Z-2226-2023 · Initiated June 21, 2023

    Recall

    Recall Number
    Z-2226-2023
    Event Number
    92530
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 21, 2023
    Posted
    July 21, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

    Reason

    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.

    Action

    Only 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.

    Distribution

    International distribution to the countries of Israel and Serbia.

    Quantity

    2 clinician tablets