BEUDAMED
    FDA Recall Terminated

    BirthNet OB Data Management System 91861

    Recall: Z-0115-06 · Initiated October 13, 2005

    Recall

    Recall Number
    Z-0115-06
    Event Number
    33769
    Firm
    Spacelabs Medical Incorporated
    FEI Number
    3010157426
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 13, 2005
    Posted
    November 1, 2005
    Terminated
    January 17, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    BirthNet OB Data Management System 91861

    Reason

    Potential for incorrect weight to be displayed.

    Action

    On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.

    Distribution

    Distribution was to 44 medical facilities/hospitals nationwide.

    Quantity

    44 devices