# FDA recall Z-2058-2018

> **Zeiss, Carl Inc** · Class II · device recall initiated 2018-05-08.

## 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 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

USA (nationwide)

## Key facts

- **Recall number:** Z-2058-2018
- **Recalling firm:** Zeiss, Carl Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-08
- **Report date:** 2018-06-20
- **Termination date:** 2020-04-21

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Thornwood, NY, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2058-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2058-2018. Source: US FDA. Licensed CC0.

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