Drug recall
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
FDA recall event 89524 · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Event ID | 89524 |
|---|---|
| Recall numbers | Z-0723-2022 |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Product type | Devices |
| Products | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. |
| Initiation date | Jan 14, 2022 |
| Report date | Mar 16, 2022 |
| 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: