BEUDAMED
    FDA Recall Terminated

    CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10 in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.

    Recall: Z-1837-2019 · Initiated April 15, 2019

    Recall

    Recall Number
    Z-1837-2019
    Event Number
    82641
    Firm
    Med Tec Inc
    FEI Number
    1000143606
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 15, 2019
    Terminated
    October 5, 2020
    Address
    1401 8th St SE, Orange City, IA, 51041-7463

    Description

    CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10 in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.

    Reason

    There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.

    Action

    The firm disseminated the notices by email on 04/15/2019 to their consignees. The notices stated the problem and provided mitigation strategies to employ to reduce the risk to the patient. The consignee was also provided the option to return the unit.

    Distribution

    Worldwide distribution - US Nationwide distributed in the states of CA, HI, PA, KY, FL, WI, AK and countries of Australia, Canada, Italy, Netherlands, Switzerland, Peru.

    Quantity

    28 units