Company:Trek Diagnostic Systems Date of Enforcement Report 9/12/12 Class lll: PRODUCT VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and...Read More

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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 9/12/12 Class ll: PRODUCT Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters...Read More

Company:Capintec Inc. Date of Enforcement Report 9/12/12 Class ll: PRODUCT Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity. Recall Number Z-2312-2012 REASON Customers who received a Capintec Captus 3000...Read More