FDA recall Z-1837-2019

Med Tec Inc · Class II · 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.

Reason for recall

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

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.

Key facts

Status
Terminated
Initiation date
2019-04-15
Report date
2019-06-26
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Orange City, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1837-2019