Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0770-2020 — 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 p

U.S. FDA — Device Enforcement · United States · 2018-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0770-2020
Date of alert: 2018-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carl Zeiss Meditec, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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