medical Class II Updated 2019-06-26

Med Tec Inc recalls CIVCO Solstice(TM) SRS Immobilization System, Part Numbers:

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →