Company: Hitachi Medical Corporation Date of Enforcement Report 7/30/2008 Class:lll PRODUCT EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information, Recall # Z-1571-2008 REASON Miscalculation reading. A software error in the firm’s EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 7/30/2008 Class:ll PRODUCT a) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 – FC 500 with UPS, Automated differential cell counter; Part Number: 626553; Recall # Z-2016-2008; b) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 –...Read More