FDA Device

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

Hazard

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.

What You Should Do

Remedy

The Company will immediately notify by direct contact (when available) and/or express courier each first line purchaser and/or known user site with informing them of the risk, how to prevent it and the notice of action. The Company will dispatch factory trained service representatives to perform following actions: o Installation of Hot Fix # 14 (or newer) for ZEN 2.3 o Installation of Firmware 1 .209 (or newer) on nodes x l 5 and x l 9 (Main Controller 2)

Products

Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
Brand
Zeiss, Carl Inc
UPC
432332-9020-000

Units Affected

8