Company: LMS Medical Systems Ltd, Date of Enforcement Report:5/3/2006 Class:lI PRODUCT CALM software. This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data...Read More

Company: Hospira Inc., Date of Enforcement Report:3/15/2006 Class:lI PRODUCT Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09, Recall # Z-0601-06 REASON Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen. CODEList numbers 12384-04, software version 4.08 and 4.09 RECALLING FIRM/MANUFACTURER Hospira, Inc., Morgan Hill , CA ,...Read More