Drug recall
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers…
FDA recall event 65109 · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Event ID | 65109 |
|---|---|
| Recall numbers | Z-1440-2013 |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three)… |
| Initiation date | Apr 18, 2013 |
| Report date | Jun 12, 2013 |
| Termination date | Jun 26, 2013 |
| City | Dublin |
| State | CA |
| Country | United States |
| FEI number | 2918630 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: