Device recall
Z-1837-2019: CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04…
FDA device recall · Class II · Med Tec Inc
Key facts
| Recall number (Z-number) | Z-1837-2019 |
|---|---|
| Recall event | 82641 |
| 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… |
| Product code | IYE |
| Recalling firm | Med Tec Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K182079 |
| FEI number | 1000143606 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database