Company:Siemens Medical Solutions USA, Inc.. Date of Enforcement Report: 10/30/2013 Class ll: PRODUCT Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the...Read More

Company: AGFA Corp. Date of Enforcement Report: 10/30/2013 Class ll: PRODUCT IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). Recall Number Z-0035-2014 REASON System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. RECALLING...Read More

Company: GE Healthcare It Date of Enforcement Report: 10/30/2013 Class lI: PRODUCT Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various...Read More

Company: Bio-Rad Laboratories Date of Enforcement Report: 10/30/2013 Class lIl: PRODUCT FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. Recall Number Z-0032-2014 REASON The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data...Read More