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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Solstice(TM) SRS Immobilization System

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 Class 2 Device Recall CIVCO Solstice(TM) SRS Immobilization Systemsee related information
Date Initiated by FirmApril 15, 2019
Create DateJune 18, 2019
Recall Status1 Terminated 3 on October 05, 2020
Recall NumberZ-1837-2019
Recall Event ID 82641
510(K)NumberK182079 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductCIVCO 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.
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
Recalling Firm/
Manufacturer		 Med Tec Inc
1401 8th St SE
Orange City IA 51041-7463
For Additional Information ContactHeather Wilkerson
319-248-6657
Manufacturer Reason
for Recall		There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce28 units
DistributionWorldwide distribution - US Nationwide distributed in the states of CA, HI, PA, KY, FL, WI, AK and countries of Australia, Canada, Italy, Netherlands, Switzerland, Peru.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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