BEUDAMED
    FDA Recall Open, Classified

    Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units

    Recall: Z-2270-2023 · Initiated April 10, 2023

    Recall

    Recall Number
    Z-2270-2023
    Event Number
    92391
    Firm
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku
    FEI Number
    3002808139
    Product Code
    IYB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 10, 2023
    Posted
    July 31, 2023
    Address
    1 Kyoto Japan

    Description

    Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units

    Reason

    Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.

    Action

    On 4/10/23, recall notices were emailed to customers who were asked to do the following: 1)The Tube Column Assembly is secured by eight fixing bolts located at the base of the assembly. If while using the system, you observe loose, or missing bolts then please discontinue use of the system and call your authorized Service Provider. 2) Schedule a time with their Distributer to have their system updated. 3) Post the notice within their facility so that all users are aware of how to avoid this issue until the corrective actions has been completed. 4) Complete and return the Customer Acknowledgement and Receipt of Letter form to [email protected] The National Technical Support phone number was provided: 844-487-2767

    Distribution

    U.S. Nationwide distribution.

    Quantity

    1836