FDA-Device2018-06-20Class II

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.

Zeiss, Carl Inc
Hazard

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

Sold states
USA (nationwide)
Affected count
1070 units to US
Manufactured in
1 Zeiss Dr, N/A, Thornwood, NY, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2058-2018

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