BEUDAMED
    FDA Recall Terminated

    Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.

    Recall: Z-0918-2017 · Initiated November 20, 2016

    Recall

    Recall Number
    Z-0918-2017
    Event Number
    75834
    Firm
    Shimadzu Medical Systems
    FEI Number
    1000125362
    Product Code
    IZO
    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 High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.

    Reason

    Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.

    Action

    The firm, Shimadzu Medical Systems USA, sent an "Urgent Medical Device Recall notice" and Field Safety Notice dated 11/20/16 to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray High Voltage Generator UD150B-40. Customers are informed of how to identify the affected products, corrective action plan by Shimadzu, and the actions to be taken by customers. Customers that have not received a call or visit from Shimadzu are instructed to call Shimadzu Medical Systems National Technical Support at (800) 228-1429. Shimadzu sent an updated "URGENT Voluntary Medical Device Recall Notice" letter dated 11/30/16 to its customers on 11/30/16 to inform them that Shimadzu Corp. has identified a potential issue in the Shimadzu X-ray High Voltage Generator UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube. The letter informs the customers that when operated for prolonged periods of time at low rate serial exposure, the heat load capacity of the X-ray anode disc (target) may become damaged and leak insulating oil. Customers with questions are instructed to contact Shimadzu National Technical Support at (800) 228-1429.

    Distribution

    US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.

    Quantity

    13 units