Company:Varian Medical SystemsDate of Enforcement Report 2/25/2009 Class:ll PRODUCT Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Recall # Z-0861-2009 REASON Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and...Read More

Company:Haemonetics Software Solution Div Date of Enforcement Report 2/25/2009 Class:ll PRODUCT Prelude module of Symphony System software. Recall # B-0520-09 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Haemonetics Software Solution Div., Rosemont, IL, by telephone on November 14, 2008 and follow-up letters dated November 18, 2008. Firm initiated recall is ongoing....Read More

Company:Mako Surgical Date of Enforcement Report 2/25/2009 Class:ll PRODUCT a) Femoral Array, Model number: 0150ARR00001 and b) Tibial Array, Model number: 0150ARR00002. The devices are accessories used with MAKO’s Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to...Read More