Z-2058-2018 Class II Terminated
FDA device recall Z-2058-2018 was initiated by Zeiss, Carl Inc on May 8, 2018 and is designated Class II. 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. The recall status is terminated (terminated April 21, 2020). Affected quantity: 1070 units to US.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- May 8, 2018
- Termination Date
- April 21, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1070 units to US
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.
Distribution Pattern
USA (nationwide)
Code Information
Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes