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Leica Biosystems Richmond Inc. recalls CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase fin
Recalled June 29, 2016 · FDA recall Z-2039-2016 · Leica Biosystems Richmond
Hazard
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. · FDA Class III
Units
283 systems
Sold at
Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.
Description
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.
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.
Manufacturer(s)
Leica Biosystems Richmond Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →