Device product
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.
Z-1837-2019
Product summary
- Firm
- Med Tec Inc
- Event
- Event 82641
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-1837-2019
Official wording
Reason: There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Code information: Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.