Company: Medtronic IncDate of Enforcement Report: 7/28/04 Class: II PRODUCT a) Kappa Model 701 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for bradycardia (slow heart rhythm). Model 701 KVDD IPGs provide atrial sensing and do not provide atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing; also by...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 7/28/04 Class: II PRODUCT Synchron Systems Lipid Calibrator (HDLD) Part Number: 650218. Recall # Z-1153-04. REASON Incorrect units are printed in labeling but not in software. CODE Kit: M302210 Level 1; M302211 Level 2; M302212. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on October 8, 2003....Read More