Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2441-2018Class II

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

Carl Zeiss Microscopy, LLC / initiated 2018-05-29 / Terminated / root cause: software

Zeiss, Carl Inc began a recall of Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2441-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Carl Zeiss Microscopy, LLC
Product
Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
Product code
RGW Uv/Ir Research
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.
Root cause tag
software
FDA root cause
Radiation Control for Health and Safety Act
Action
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)
Quantity in commerce
8
Distribution
US Nationwide Distribution
Product codes and lots
432332-9020-000

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2441-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2441-2018Class IITerminatedFDA Mandated