Company: Sonosite, Inc. Date of Enforcement Report:4/12/2006 Class:lI PRODUCT SonoCalc IMT 3.0, windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery, Recall # Z-0713-06 REASON When SonoCalc IMT...Read More

Company:Fischer Imaging Corporation, Date of Enforcement Report:4/19/2006 Class:lI PRODUCT SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06 REASON Software upgrade to preclude lost images during mammography procedure. CODE Software versions earlier than 5.2.2 RECALLING FIRM/MANUFACTURER Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is...Read More

Company: bioMerieux, Inc, Date of Enforcement Report:4/12/2006 Class:lI PRODUCT BacT ALERT Classic 120 System and 240 System, Recall # B-0865-6 REASON BacT/ALERT Classic Systems, with a software glitch or defect, were distributed. CODE All Models RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, by letter dated September 17, 2004, firm initiated recall is ongoing. VOLUME OF PRODUCT...Read More