BEUDAMED
    FDA Enforcement Class II Terminated

    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

    Recall: Z-2898-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2898-2016
    Event ID
    74955
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2016
    Initiation Date
    August 5, 2016
    Classification Date
    September 27, 2016
    Termination Date
    October 20, 2016
    Address
    18000 Devonshire Street, N/A, Northridge, CA, 91325-1219, United States

    Description

    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

    Reason

    Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

    Code Info

    n/a

    Distribution

    Nationwide Distribution to TN, MN, and WA

    Quantity

    33 units