Device recall
Z-2058-2018: Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3…
FDA device recall · Class II · Zeiss, Carl Inc
Key facts
| Recall number (Z-number) | Z-2058-2018 |
|---|---|
| Recall event | 80115 |
| Product | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research. |
| Product code | REM |
| Recalling firm | Zeiss, Carl Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2020 |
| FEI number | 2431026 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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