Drug recall
OPMI LUMERA 300, REF 6137
FDA recall event 93146 · Class II · Carl Zeiss Suzhou Co., Ltd.
Key facts
| Event ID | 93146 |
|---|---|
| Recall numbers | Z-0183-2024 |
| Recalling firm | Carl Zeiss Suzhou Co., Ltd. |
| Product type | Devices |
| Products | OPMI LUMERA 300, REF 6137 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under… |
| Initiation date | Aug 18, 2023 |
| Report date | Nov 1, 2023 |
| City | Suzhou |
| Country | China |
| FEI number | 3008564898 |
At a glance
- 1–9 Products in this recall
- None 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: