BEUDAMED
    FDA Recall Terminated

    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

    Recall: Z-1855-2021 · Initiated May 5, 2021

    Recall

    Recall Number
    Z-1855-2021
    Event Number
    87904
    Firm
    Abbott Laboratories Inc. (St Jude Medical)
    FEI Number
    1000139754
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    May 5, 2021
    Terminated
    June 18, 2024
    Address
    1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789

    Description

    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

    Reason

    Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

    Action

    Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient.

    Distribution

    US Nationwide distribution in the states of MI, KS, MO, TX.

    Quantity

    8 units