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Terminated

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

FDA Recall Z-2441-2018 · Posted None

Recalling FirmZeiss, Carl Inc
Recall StatusTerminated
Product CodeRGW
Date Initiated2018-05-29
Date Terminated2024-07-26
Product Quantity8

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.

Firm 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)

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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