BEUDAMED
    FDA Recall Terminated

    Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software

    Recall: Z-0449-2009 · Initiated September 24, 2008

    Recall

    Recall Number
    Z-0449-2009
    Event Number
    49712
    Firm
    Hologic, Inc.
    FEI Number
    1221300
    Product Code
    KGI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 24, 2008
    Posted
    December 29, 2008
    Terminated
    March 7, 2016
    Address
    35 Crosby Dr, Bedford, MA, 01730

    Description

    Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software

    Reason

    Software error may lead to a high estimate of major fracture probability.

    Action

    Hologic notified customers by telephone on 9/23 and 24/08 and instructed them to not use the software. A customer notification letter was sent via FedEx to customers on September 25, 2008.The letter requested de-installation of the software and return of the software to Hologic in a pre-paid envelope.

    Distribution

    Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.

    Quantity

    15 software discs