BEUDAMED
    FDA Recall Terminated

    Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.

    Recall: Z-0531-04 · Initiated January 28, 2004

    Recall

    Recall Number
    Z-0531-04
    Event Number
    28214
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2004
    Posted
    February 10, 2004
    Terminated
    January 18, 2005
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.

    Reason

    A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.

    Action

    Firm will send a Product Performance Update in all new shipments of the model 7311 version 5.0B software and it will be provided to all customers already receiving the version B software. When available, version 5.0c will be provided to customers with A or B software.

    Distribution

    undisclosed, assumed to be nationwide.