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 analysis, display and archiving functions, Recall # Z-0821-06
REASON
IA deficiency in the software code can, in certain circumstances, cause data for the wrong patient to be displayed in the Tracing Review screen when a user is acknowledging an Alert.
CODE
Software version 02.09.01
RECALLING FIRM/MANUFACTURER
LMS Medical Systems Ltd, Montreal, Canada, by telephone on January 11, 2005 and by email or fax on/about January 13, 2005, firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
AL, IL, MD, NH, OH and Canada
