BEUDAMED
    FDA Recall Terminated

    Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    Recall: Z-1726-2009 · Initiated April 7, 2009

    Recall

    Recall Number
    Z-1726-2009
    Event Number
    51692
    Firm
    Hologic, Inc.
    FEI Number
    1221300
    Product Code
    KGI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 7, 2009
    Posted
    August 25, 2009
    Terminated
    November 29, 2010
    Address
    35 Crosby Dr, Bedford, MA, 01730

    Description

    Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    Reason

    System may not turn off at the end of the x-ray and cause additional x-ray exposure

    Action

    Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.

    Distribution

    Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.

    Quantity

    1914 units total