Recall Z-2441-2018— Zeiss, Carl Inc

Class II · Terminated

Class II FDA medical device recall by Zeiss, Carl Inc, initiated 2018-05-29, terminated 2024-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope. Reason: 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..

Recalling firm
Zeiss, Carl Inc
Classification
Class II
Status
Terminated
Initiated
2018-05-29
Terminated
2024-07-26
Firm location
Thornwood, NY, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.