Med Tec Inc recalls CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixati

Recalled June 26, 2019 · FDA recall Z-1837-2019 · Med Tec

Hazard

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

Units

28 units

Sold at

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.

Description

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

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.

Manufacturer(s)

Med Tec Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →