FDA Device recall Z-2058-2018
Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes by Zeiss Carl, citing in certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2058-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-08 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zeiss Carl |
| Distribution | US |
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.
Identifiers
| code_info | Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2058-2018%22
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