BEUDAMED
    FDA Recall Open, Classified

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

    Recall: Z-0399-2024 · Initiated October 6, 2023

    Recall

    Recall Number
    Z-0399-2024
    Event Number
    93315
    Firm
    LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France
    FEI Number
    3012834372
    Product Code
    JAI
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 6, 2023
    Posted
    November 21, 2023

    Description

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

    Reason

    Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.

    Action

    BizLink s notified customer via email with delivery and read confirmation and with the Field Safety Notice (FSCA Ref: UMCU-638) on October 6, 2023. Letter states reason for recall, health risk and action to take: BizLink technical support team will contact customers shortly to organize the deployment of the hot fix in the proton-therapy treatment centers. While waiting for the hot fix, BizLink recommend that customers implement the following action at the customer software level to avoid this problem: Send a stopFast command just after reactivating the motionEnable / the E-stop / the collision detection by Safety Laser and before sending any other motion command. A hot fix to correct this bug has been developed. BizLink shall provide this hot fix (version OSS 6.1 and version OSS 7.3) and the detailed documentation so that customers can deploy the new software version on clinical sites available on October 27, 2023 at the latest. If you require further clarification, please feel free to contact our BizLink Team ([email protected]). Please return the signed copy of the FSN to BizLink ([email protected]) within 10 working days

    Distribution

    US Nationwide distribution in the states of MA, TN.

    Quantity

    3 units