Company:RAYSEARCH LABORATORIES AB. Date of Enforcement Report 1/24/2018 Class lI: PRODUCT RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and...Read More

Company:Phadia US Inc.Date of Enforcement Report 1/24/2018 Class lI: PRODUCT Phadia 1000 Instrument, Article Number 12-3800-01.. Recall Number Z-0387-2018 REASON The “Retry” command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results RECALLING FIRM/MANUFACTURER Phadia US Inc, Portage, MI. on 7/5/2017. Voluntary firm...Read More