Company: Welch Allyn Protocol, Inc Date of Enforcement Report 3/11/2009 Class:l PRODUCT Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”). Recall # Z-1006-2009 REASON Reliability issues – potential to shock a non shockable rhythm or not shocking a shockable rhythm; CODE Software version 2.02 or lower. The ECG analysis/noise issue...Read More

Company: Smiths Medical MD, Inc Date of Enforcement Report 3/11/2009 Class:ll PRODUCT a) Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. The Medfusion 3500 pump is a small, lightweight and portable syringe infusion pup. The pump offers a variety of delivery modes to program to meet specific patient care needs. The Medfusion...Read More

Company: Zimmer, Inc Date of Enforcement Report 3/11/2009 Class:ll PRODUCT Orthosoft Navitrack, OS Unicondylar Knee 1.0 – Universal; software application for orthopedic surgical stereotaxic instrument. Recall # Z-0985-2009 REASON Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use...Read More