Recall – UV Disinfection unit

Company: Zeiss, Carl Inc.
Date of Enforcement Report: 7/25/2018
Class II:

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

Recall Number: Z-2441-2018

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/MANUFACTURER
Zeiss, Carl Inc., Thornwood, NYon 5/29/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8

DISTRIBUTION
Nationwide

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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