BEUDAMED
    FDA Enforcement Class II 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 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1569-2014
    Event ID
    67927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2014
    Initiation Date
    April 3, 2014
    Classification Date
    May 8, 2014
    Termination Date
    June 25, 2015
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    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.

    Code Info

    Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001

    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)