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Recall Observatory FDA recall evidence

Device product

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

Z-2441-2018

May 29, 2018

Class II

Product summary

Firm
Zeiss, Carl Inc
Event
Event 80418
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-2441-2018

Official wording

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.

Code information: 432332-9020-000

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.