Company:Toshiba Medical Systems Co.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall # Z-0005-2009 REASON Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in...Read More

Company:Hologic Inc.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT 1) Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body...Read More

Company:Carl Zeiss Meditec Inc.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of...Read More

Company:AGFA Corp.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa’s Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-1889-2009 REASON After opening and closing a study on a Central Monitoring System while...Read More