Device recall
Z-1440-2013: Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI…
FDA device recall · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Recall number (Z-number) | Z-1440-2013 |
|---|---|
| Recall event | 65109 |
| Product | Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to… |
| Product code | EPT |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2013 |
| FEI number | 2918630 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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