FDA recall Z-2058-2018

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

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

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