CIVCO Solstice — Class II medical device recall Z-1837-2019
Terminated recall by Med Tec Inc, reported 2019-06-26, distributed nationwide. There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or tre
| Recall number | Z-1837-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Med Tec Inc, Orange City, IA, United States |
| Recall initiated | 2019-04-15 |
| Classified | 2019-06-18 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, IT, NL, PE |
| Quantity | 28 units |
| UPC / GTIN / UDI-DI | 00841439112489, 00841439112496 |
| Lot numbers | M602380, M680480, M680530, M789100, M789110, M839690, M847590, M870360, M938500 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1837-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.