BEUDAMED
    FDA Recall Open, Classified

    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40

    Recall: Z-0655-2022 · Initiated December 16, 2021

    Recall

    Recall Number
    Z-0655-2022
    Event Number
    89253
    Firm
    Shimadzu Medical Systems
    FEI Number
    1000125362
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    December 16, 2021
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328

    Description

    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40

    Reason

    Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

    Action

    On 12/13/2021, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to distributors who hand-delivered to customers informing them that there is a potential issue with the adjustment procedure for the calibration of the x-ray generators for the Digital Angiography Systems and occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards. Customers are instructed to: -Check their systems for the affected generators. -Contact their distributor to schedule a system update and calibration. -If customers feel there are any issues with their system, they are asked to discontinue use of the system and contact their local service providers. The Recalling Firm has identified that affected units and have informed the authorized service representatives. The authorized servicers should be contacting customers to schedule time to implement the corrective action (update and calibrate). Customers can contact the Recalling Firm's National Technical Support at: Toll Free: (844)487-2767 available 8:00 a.m. to 5:00 p.m. Monday thru Friday On 01/07/2022, an updated "Urgent: Voluntary Medical Device Recall Letter" will be communicated to customer to provide additional instruction on how to identify an issue with their system which would indicated to cease using until the system has been corrected.

    Distribution

    U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

    Quantity

    28 systems