BEUDAMED
    FDA Enforcement Class II 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 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1837-2019
    Event ID
    82641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med Tec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2019
    Initiation Date
    April 15, 2019
    Classification Date
    June 18, 2019
    Termination Date
    October 5, 2020
    Address
    1401 8th St SE, N/A, Orange City, IA, 51041-7463, United States

    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.

    Code Info

    Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500

    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