BEUDAMED
    FDA Enforcement Class II Terminated

    Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    Recall: Z-1459-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1459-2020
    Event ID
    84883
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Braemar Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 18, 2020
    Initiation Date
    January 22, 2020
    Classification Date
    March 10, 2020
    Termination Date
    May 27, 2022
    Address
    1285 Corporate Center Dr Ste 150, Eagan, MN, 55121-1278, United States

    Description

    Braemar Manufacturing LLC DL900 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.

    Code Info

    All devices manufactured or distributed prior to 01/01/2020 are affected.

    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