FDAOctober 16, 2018device
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 imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
carl zeiss mediteccarlcarl zeiss
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOPMI LUMERA 300, REF 61372023-08-18
- FDAZEISS Axio Observer 5 microscope, Product material no. 431006-9901-0002022-06-24
- FDAZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.2022-03-16
- FDACIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex2022-01-14
- FDAChassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"2021-07-08
- FDAIOLMaster 7002020-12-07
- FDACarl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.2020-08-06
- FDACarl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.2020-08-06
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