Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CIVCO Solstice(TM) SRS Immobilization System Recalled by Med Tec Inc Due to There is a potential for movement of the...

Date: April 15, 2019
Company: Med Tec Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Med Tec Inc directly.

Affected Products

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.

Quantity: 28 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Med Tec Inc

Med Tec Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report