FDA Recall
Terminated
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: Z-0821-06
·
Initiated January 11, 2005
Recall
- Recall Number
- Z-0821-06
- Event Number
- 35138
- Firm
- LMS Medical Systems Ltd
- FEI Number
- 3002687025
- Product Code
- HGM
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 11, 2005
- Posted
- April 27, 2006
- Terminated
- June 27, 2006
- Address
- 5252 De Maisonneuve West, Suite 314, Montreal Canada
Description
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.
Reason
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
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.
Distribution
AL, IL, MD, NH, OH and Canada
Quantity
8 units