Agency classClass IIOur severity:High FDA (Devices)·Z-0770-2020·Announced 2020-01-08

Carl Zeiss PLEX Elite 9000 Recalled for Electrical Shock Hazard

Carl Zeiss Meditec is recalling 151 PLEX Elite 9000 Swept-Source OCT devices because a design fault may expose operators to hazardous voltage when contacting the metal enclosure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of electrical shock (hazardous voltage) to the operator, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Carl Zeiss Meditec, Inc. is recalling 151 units of the PLEX Elite 9000 Swept-Source OCT (SS-OCT) imaging device. The recall is due to a design fault that may expose the operator to hazardous voltage when contacting the metal enclosure, including mounting screws, around the up/down switch under certain fault conditions.

The affected devices were distributed worldwide, including in the United States and various international markets. The PLEX Elite 9000 is a non-contact, high-resolution imaging device intended for in-vivo viewing and cross-sectional imaging of posterior ocular structures.

No specific instructions for consumers or operators are provided in the source text. Users of the affected devices should contact the manufacturer for further guidance on the recall and potential corrective actions.

The recalled product

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…
Manufacturer: Carl Zeiss Meditec, Inc.
Category: Medical Device — Ophthalmic Imaging
Hazard: electrical-shock
Affected units: 151

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

OBO /HJO Serial Numbers: PE9000-001
PE9000-002
PE9000-003
PE9000-004
PE9000-005
PE9000-006
PE9000-007
PE9000-008
PE9000-009
PE9000-0010
PE9000-0011
PE9000-0012
PE9000-0013
PE9000-0014
PE9000-0015
PE9000-0016
PE9000-0020
PE9000-0021
PE9000-0022
PE9000-0023

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · Carl Zeiss Meditec, Inc.

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Same hazard · electrical shock