Solstice SRS Immobilization System recallZ-1837-2019 · Med Tec Inc · initiated Apr 15, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Med Tec Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1837-2019
- Status
- Terminated
- Initiated by the company
- Apr 15, 2019
- Recalling firm
- Med Tec Inc
- Quantity
- 28 units
- Product code
- IYE
- FDA submissions
- K182079
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Solstice™ SRS Immobilization System CHS04Medtec, Inc. · Accelerator, linear, medical1 recall1 report
- Solstice™ SRS Immobilization System CHS03Medtec, Inc. · Accelerator, linear, medical1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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