BEUDAMED
    FDA Recall Completed

    Medtronic SynchroMed, Model A10

    Recall: Z-0522-2024 · Initiated July 13, 2020

    Recall

    Recall Number
    Z-0522-2024
    Event Number
    93401
    Firm
    Medtronic Inc.
    FEI Number
    2182208
    Product Code
    LKK
    Status
    Completed
    Root Cause
    Software Design Change
    Initiated
    July 13, 2020
    Posted
    December 9, 2023
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic SynchroMed, Model A10

    Reason

    The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

    Action

    Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342.

    Distribution

    Foreign Distribution

    Quantity

    2543 units