Med Tec Inc: Medical Device Recall in 2019 - (Recall #: Z-1837-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 15, 2019

Date Posted: June 26, 2019

Recall Number: Z-1837-2019

Event ID: 82641

Reason for Recall:

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

Status: Terminated

Product Quantity: 28 units

Code Information:

Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated