Company:Vital Images, Inc.Date of Enforcement Report 5/26//2010 Class:ll PRODUCT Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Recall # Z-1600-2010 REASON Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea...Read More

Company:Animas Corp.Date of Enforcement Report 5/26//2010 Class:lll PRODUCT One Touch Ping Insulin Pump using ezManager Max diabetes management software. Recall # Z-1560-2010 REASON Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food...Read More