Company:Varian Medical Systems Inc. Date of Enforcement Report:7/4/2007 Class:ll PRODUCT LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1., Recall # Z-0978-2007 REASON A software anomaly in a medical device used for patient treatment could result in accidental or unintended radiation exposure. The tilt rotation compensation algorithm does not adequately...Read More

Company:Toshiba American Med Sys Inc Date of Enforcement Report:7/4/2007 Class:ll PRODUCT a) Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software, Recall # Z-0985-2007; b) Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software, Recall # Z-0986-2007 REASON When using the LV measurement function and making numerous measurements the value displayed...Read More