Company: Leica Biosystems Richmond Inc.
Date of Enforcement Report 6/29/2016
Class lI:
PRODUCT
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
Recall Number Z-2039-2016
REASON
Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
RECALLING FIRM/MANUFACTURER
Leica Biosystems Richmond Inc, Richmond, IL on 5/2/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
283 systems
DISTRIBUTION
Nationwide and Internationally
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