Recall Z-1837-2019 ยท IYE Accelerator, Linear, Medical
Med Tec Inc
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 attache
| Date | Apr 15, 2019 |
| Status | Terminated |
| Reason | There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask Medtec Inc. Dba Civco Medical Solutions, Sep 7, 2018 |