BEUDAMED
    FDA Recall Terminated

    Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.

    Recall: Z-1569-2014 · Initiated April 3, 2014

    Recall

    Recall Number
    Z-1569-2014
    Event Number
    67927
    Firm
    Shimadzu Medical Systems
    FEI Number
    1000125362
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 3, 2014
    Posted
    May 8, 2014
    Terminated
    June 25, 2015
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328

    Description

    Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.

    Reason

    Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

    Action

    A Service Bulletin and a customer notification letter were sent on 4/3/2014 for all the customers who purchased the Shimadzu Digital X-Ray System (Catalog No. DAR-8000f). The notification informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.

    Quantity

    685 units total (14 units in US)