Company: GE Healthcare It Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT syngo(R) Lab Data Manager – Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help...Read More

Company: Haemonetics Software Solutions Date of Enforcement Report:12/11/2013 Class lI: PRODUCT ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Recall Number B-0008-14 REASON Blood Bank Software, with a defect or glitch, was...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. Recall Number Z-0430-2014 REASON There is the potential...Read More

Company: Cincinnati Sub-Zero Products Inc Date of Enforcement Report:12/11/2013 Class lI: PRODUCT Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol...Read More