Company:Picis, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010 REASON Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between...Read More

Company:Cyberonics, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010 REASON Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test...Read More