BEUDAMED
    FDA Recall Terminated

    Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    Recall: Z-1460-2020 · Initiated January 22, 2020

    Recall

    Recall Number
    Z-1460-2020
    Event Number
    84883
    Firm
    Braemar Manufacturing, LLC
    FEI Number
    1000520785
    Product Code
    MWJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 22, 2020
    Terminated
    May 27, 2022
    Address
    1285 Corporate Center Dr, Ste 150, Eagan, MN, 55121-1278

    Description

    Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    Reason

    An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site.

    Action

    Consignees notified via email with recall letter dated 01/22/2020. The letter identified affected product, stated reason for recall, and provided instructions on how to reset the error by following provided instructions, or to send the equipment to Braemar for repair.

    Distribution

    Nationwide. No governmental consignees or Canadian consignees. International distribution to Germany, Spain, Switzerland, France, Finland, Vietnam, Israel, France, Hong Kong, Czech Republic, Finland, Belgium, Sweden, Mexico, Lebanon, United Arab Emirates, Bolivia, Italy, and Belgium.

    Quantity

    10582