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U.S. Department of Health and Human Services

Class 2 Device Recall CALM perinatal monitoring system

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 Class 2 Device Recall CALM perinatal monitoring systemsee related information
Date Initiated by FirmJanuary 11, 2005
Date PostedApril 27, 2006
Recall Status1 Terminated 3 on June 27, 2006
Recall NumberZ-0821-06
Recall Event ID 35138
Product Classification System, Monitoring, Perinatal - Product Code HGM
ProductCALM 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.
Code Information Software version 02.09.01
FEI Number 3002687025
Recalling Firm/
Manufacturer		 LMS Medical Systems Ltd
5252 De Maisonneuve, West
Suite 314
Montreal Canada
For Additional Information ContactPamela J. Haswell
514-488-3461 Ext. 246
Manufacturer 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
FDA Determined
Cause 2		Other
ActionConsignees were first notified by telephone on 01/11/2005. A brief document was sent via email or fax on/about 01/13/2005.
Quantity in Commerce8 units
DistributionAL, IL, MD, NH, OH and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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