Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Recall Number Z-1068-2013 REASON It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a...Read More

Company:AGFA Corp. .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Recall Number Z-1070-2013 REASON Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the...Read More

Company:AGFA Corp. .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT IMPAX CV 7.8 SU3 – OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. Recall Number Z-1069-2013 REASON Software design...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. Recall Number Z-1096-2013 REASON GE...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Recall Number B-1345-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc, Auburn, WA, on 12/5/2012. Voluntary: Firm Initiated recall...Read More