Reported Jun 26, 2019 · Terminated
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head…
Med Tec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Med Tec Inc · 1401 8th St SE · Orange City, IA · 51041-7463
Is this the product you have?
- CIVCO Solstice(TM) SRS Immobilization System
- Part Numbersa) CHS03
- b) CHS04 - Product UsageThe 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
- Lot codes and dates
- Part Numbersa) CHS03
- UDI 00841439112489 Lot Numbers
M602380M680480M847590M870360 b) CHS04
- UDI 00841439112496 Lot Numbers
M680530M789100M789110M839690M938500
- Amount recalled
- 28 units
Where it was sold
Why it was recalled
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
This product could cause temporary or reversible health problems — stop using it.
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