The PLEX Elite 9000 — Class II medical device recall Z-0770-2020
Terminated recall by Carl Zeiss Meditec, Inc., reported 2020-01-08, distributed nationwide. Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contac
| Recall number | Z-0770-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec, Inc., Dublin, CA, United States |
| Recall initiated | 2018-10-16 |
| Classified | 2020-01-02 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2021-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CN, DE, FR, IL, IN, IT, JP, KR, NO, SG, TW |
| Quantity | 151 devices |
| Serial numbers | PE9000-001, PE9000-0010, PE9000-0011, PE9000-0012, PE9000-0013, PE9000-0014, PE9000-0015, PE9000-0016, PE9000-002, PE9000-0020, PE9000-0021, PE9000-0022, PE9000-0023, PE9000-0024, PE9000-0025, PE9000-0026, PE9000-0027, PE9000-0029, PE9000-003, PE9000-0030, PE9000-0031, PE9000-0032, PE9000-0033, PE9000-0034, PE9000-0035 and 126 more |
Product
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 posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0770-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.