Recall Z-2058-2018— Zeiss, Carl Inc
Class II · Terminated
Class II FDA medical device recall by Zeiss, Carl Inc, initiated 2018-05-08, terminated 2020-04-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit..
- Recalling firm
- Zeiss, Carl Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-08
- Terminated
- 2020-04-21
- Firm location
- Thornwood, NY, United States
Product description
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.
Reason for recall
In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.