Recall Z-1837-2019— Med Tec Inc

Name: FDA recall Z-1837-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-15

Class II · Terminated

Class II FDA medical device recall by Med Tec Inc, initiated 2019-04-15, terminated 2020-10-05. It names one FDA 510(k) clearance: K182079. Product: 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: There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment..

Recalling firm: Med Tec Inc
Classification: Class II
Status: Terminated
Initiated: 2019-04-15
Terminated: 2020-10-05
Firm location: Orange City, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K182079 — Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic MaskMedtec Inc. Dba Civco Medical Solutions·cleared 2018-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.