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.
FDA Recall Z-0821-06 · Posted 2006-04-27
Recalling FirmLMS Medical Systems Ltd
Recall StatusTerminated
Product CodeHGM
Date Initiated2005-01-11
Date Terminated2006-06-27
Product Quantity8 units
Reason for Recall
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
Firm Action
Consignees were first notified by telephone on 01/11/2005. A brief document was sent via email or fax on/about 01/13/2005.
Root Cause
Other
Distribution Pattern
AL, IL, MD, NH, OH and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.