Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 6/15/2011 Class ll: PRODUCT 1) Toshiba Infinix-i, INFX-8000C. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1871-2011; 2) Toshiba Infinix-i, INFX-8000F. The expected usage of these devices is for fluoroscopy studies for various...Read More

Company: Boston Scientific CRM Corp Date of Enforcement Report 6/15/2011 Class ll: PRODUCT Boston Scientific’s LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442...Read More