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
Check against the official notice below — it lists the full affected range.
Med Tec Inc. is recalling the CIVCO Solstice Tilting Head Fixation System (Part Numbers CHS03 and CHS04) because there is a potential for the device to move during patient setup and/or treatment. The system consists of a baseplate and bowl with a locking mechanism. A total of 28 units were distributed worldwide, including in the United States in California, Hawaii, Pennsylvania, Kentucky, Florida, Wisconsin, and Alaska, as well as in Australia, Canada, Italy, Netherlands, Switzerland, and Peru.
The affected devices can be identified by their part numbers and lot numbers: Part Number CHS03 includes Lot Numbers M602380, M680480, M847590, and M870360 (UDI 00841439112489), and Part Number CHS04 includes Lot Numbers M680530, M789100, M789110, M839690, and M938500 (UDI 00841439112496). The source document does not specify a remedy for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Reason for recall: There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment. 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. Quantity: 28 units Lot/code info: Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.