PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 26, 2019 Initiated: April 15, 2019 #Z-1837-2019

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.

Reason for Recall

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

Details

Recalling Firm
Med Tec Inc
Units Affected
28 units
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.
Location
Orange City, IA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Med Tec Inc. Units affected: 28 units.
Why was this product recalled? ▼
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1837-2019.

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