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Recall Observatory FDA recall evidence

Device product

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.

Z-2058-2018

May 08, 2018

Class II

Product summary

Firm
Zeiss, Carl Inc
Event
Event 80115
Status
Terminated
Classification
Class II
Quantity
1070 units to US
Official record key
device-enforcement:Z-2058-2018

Official wording

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

Code information: Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes

Distribution pattern: USA (nationwide)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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