BEUDAMED
    FDA Enforcement Class II Terminated

    Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)

    Recall: Z-1105-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1105-2021
    Event ID
    87094
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BEMER INT. AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    January 13, 2021
    Classification Date
    February 10, 2021
    Termination Date
    July 12, 2023
    Address
    Austrasse 15, N/A, Triesen, N/A, N/A, Liechtenstein

    Description

    Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)

    Reason

    There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.

    Code Info

    All Lot Numbers

    Distribution

    US

    Quantity

    197,724 units