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.
FDA Recall Z-1837-2019 · Posted None
Recalling FirmMed Tec Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2019-04-15
Date Terminated2020-10-05
Product Quantity28 units
Reason for Recall
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Firm Action
The firm disseminated the notices by email on 04/15/2019 to their consignees. The notices stated the problem and provided mitigation strategies to employ to reduce the risk to the patient. The consignee was also provided the option to return the unit.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.