BEUDAMED
    FDA Recall Terminated

    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

    Recall: Z-0917-2017 · Initiated November 20, 2016

    Recall

    Recall Number
    Z-0917-2017
    Event Number
    75833
    Firm
    Shimadzu Medical Systems
    FEI Number
    1000125362
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 20, 2016
    Terminated
    December 11, 2017
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328

    Description

    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

    Reason

    Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

    Action

    An urgent medical device recall notice and a field safety notice dated 11/20/16 was sent to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray TV System SONIALVISION G4. Shimadzu informed their customers that they have received a report that oil had leaked from X-ray tube device of SONIALVISION G4 during examination. Customers are informed of the description of the issue, the actions planned by Shimadzu to correct the issue, and the actions that should be taken by the customer. Customers are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

    Distribution

    US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA

    Quantity

    39 units