Medical device recalls Moderate risk

Zeiss, Carl Inc recalls Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning M…

Recall date
May 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2058-2018
FDA classification
Class II
Brand / firm
Zeiss, Carl Inc
Sold / distributed
USA (nationwide)

Why it was recalled

In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.

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

What was recalled

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.

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