Company:Vital Images, Inc Date of Enforcement Report 11/7/12 Class ll: PRODUCT Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3,...Read More

Company:Elekta, Inc Date of Enforcement Report 11/7/12 Class ll: PRODUCT MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images....Read More

Company:Heartsine Technologies, Limited Date of Enforcement Report 11/7/12 Class ll: PRODUCT HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation. Recall...Read More

Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 11/7/12 Class ll: PRODUCT ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. Recall Number Z-0187-2013 REASON An anomaly has been identified with the ARIA Oncology Information System Version 11...Read More