Medical device recalls Moderate risk

Carl Zeiss Suzhou Co., Ltd. recalls OPMI LUMERA 300, REF 6137

Recall date
August 18, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0183-2024
FDA classification
Class II
Brand / firm
Carl Zeiss Suzhou Co., Ltd.
Sold / distributed
US Nationwide distribution in the states of MD, TX, CA, GA, LA.

Why it was recalled

Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OPMI LUMERA 300, REF 6137

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