Company:SCC Soft Computer Date of Enforcement Report 12/8/11 Class ll: PRODUCT Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory...Read More

Company:Cooper Surgical, Inc Date of Enforcement Report 12/8/11 Class ll: PRODUCT DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other...Read More

Company:Draeger Medical, Inc Date of Enforcement Report 12/8/11 Class ll: PRODUCT Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms). Catalog Number(s): MS18597 and MS18852. Recall # Z-0281-2012. REASON Complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by...Read More