BEUDAMED
    FDA Recall Terminated

    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.

    Recall: Z-2125-2016 · Initiated May 26, 2016

    Recall

    Recall Number
    Z-2125-2016
    Event Number
    74344
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 26, 2016
    Posted
    July 5, 2016
    Terminated
    October 27, 2016
    Address
    8200 Coral Sea St NE, Mounds View, MN, 55112-4391

    Description

    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.

    Reason

    Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.

    Action

    Medtronic sent an Urgent Field Safety Notice dated May 2016 to all affected customers. The letter described the issue and the product involved in the recall. The letter also included the "Customer Actions" for consignees to follow. Requested consignees to complete and return the Customer Confirmation Certificate to or via fax to <651-367-0612> to the attention of . For assistance, please contact your local Medtronic Representative or Medtronic. For questions regarding this recall call 763-514-4000.

    Distribution

    Worldwide Distribution to Austria, Belgium, China , Czech Republic , Denmark , Finland , France, Germany, Hong Kong, India , Ireland , Israel, Italy , Malaysia, Netherlands, Norway, Poland, Portugal , Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

    Quantity

    262