FDA recall Z-2441-2018

Zeiss, Carl Inc · Class II · device

Product

Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

Reason for recall

Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to harmful UV radiation.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2018-05-29
Report date
2018-07-25
Termination date
2024-07-26
Voluntary/Mandated
FDA Mandated
Location
Thornwood, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2018