BEUDAMED
    FDA Recall Terminated

    The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.

    Recall: Z-2166-2010 · Initiated February 2, 2009

    Recall

    Recall Number
    Z-2166-2010
    Event Number
    55507
    Firm
    Zoe Medical Incorporated
    FEI Number
    3003294644
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    February 2, 2009
    Posted
    August 3, 2010
    Terminated
    August 3, 2010
    Address
    460 Boston St, Topsfield, MA, 01983-1223

    Description

    The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.

    Reason

    Touch panel may become unresponsive.

    Action

    Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.

    Distribution

    Nationwide Distribution -- MA and MD.

    Quantity

    62