Z-1837-2019Class II

CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 -

Name: Z-1837-2019 CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 -
Creator: Med Tec Inc
Published: 2019-04-15
License: https://open.fda.gov/license/

Medtec LLC / initiated 2019-04-15 / Terminated / root cause: design

FDA source

Med Tec Inc began a recall of CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a... on 2019-04-15. FDA classified it as Class II and gives the reason as "There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1837-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-15
Posted: 2019-06-18
Terminated: 2020-10-05
Recalling firm: Medtec LLC
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Root cause tag: design
FDA root cause: Device Design
Action: The firm disseminated the notices by email on 04/15/2019 to their consignees. The notices stated the problem and provided mitigation strategies to employ to reduce the risk to the patient. The consignee was also provided the option to return the unit.
Quantity in commerce: 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.
Product codes and lots: Part Numbers: a) CHS03, UDI 00841439112489 Lot Numbers: M602380, M680480, M847590, M870360 b) CHS04, UDI 00841439112496 Lot Numbers: M680530, M789100, M789110, M839690, M938500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1837-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1837-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-18

Product code IYE

K182079Class IISolstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic MaskMedtec Inc. Dba Civco Medical Solutions / cleared 2018-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)