Company: Sunquest Information Systems, Inc., Date of Enforcement Report 9/24/2008 Class:ll PRODUCT Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2052-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Sunquest...Read More

Company: Sunquest Information Systems, Inc., Date of Enforcement Report 9/24/2008 Class:ll PRODUCT Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2039-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER...Read More

Company: Philips Medical Systems Date of Enforcement Report 9/24/2008 Class:ll PRODUCT EasyVision RAD – Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard...Read More

Company: Intuitive Surgical, Inc, Date of Enforcement Report 9/24/2008 Class:ll PRODUCT Intuitive Surgical DA Vinci Surgical System, Mode; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02. The IS2000 CPG is used during cardiac ablation procedures, Recall # Z-1811-2008 REASON The product has a software interface problem. When the product is connected to the...Read More

Company: Intuitive Surgical, Inc., Date of Enforcement Report 9/24/2008 Class:ll PRODUCT da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, Recall # Z-2204-2008 REASON Defective software chip may cause the system to fail and lock up. RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA, by letters, telephone and service visits beginning June 1,...Read More

Company: CAS Medical Systems, Inc, Date of Enforcement Report 9/24/2008 Class:ll PRODUCT 740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN. Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric...Read More