LMS Medical Systems Ltd CALM software, version 02.09.01 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CALM software, version 02.09.01 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.
Brand
LMS Medical Systems Ltd
Lot Codes / Batch Numbers
Software version 02.09.01
Products Sold
Software version 02.09.01
LMS Medical Systems Ltd is recalling CALM software, version 02.09.01 This software is intended for use as a central monitoring system w due to A 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A 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
Recommended Action
Per FDA guidance
Consignees were first notified by telephone on 01/11/2005. A brief document was sent via email or fax on/about 01/13/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, IL, MD, NH, OH
Page updated: Jan 10, 2026