Device recall
Z-0649-2014: Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision…
FDA device recall · Class II · Optimedica Corporation
Key facts
| Recall number (Z-number) | Z-0649-2014 |
|---|---|
| Recall event | 67150 |
| Product | Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys… |
| Product code | OOE |
| Recalling firm | Optimedica Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2014 |
| 510(k) numbers | K121091 |
| FEI number | 3005675890 |
At a glance
- 1–9 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