Drug recall
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT…
FDA recall event 83229 · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Event ID | 83229 |
|---|---|
| Recall numbers | Z-0770-2020 |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Product type | Devices |
| Products | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch. |
| Initiation date | Oct 16, 2018 |
| Report date | Jan 8, 2020 |
| Termination date | Jun 11, 2021 |
| 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: