Recall Z-0821-06 ยท HGM System, Monitoring, Perinatal
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.
| Date | Apr 27, 2006 (initiated Jan 11, 2005) |
| Status | Terminated |
| 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 |
| Root cause | Other |
| 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. |
| Quantity | 8 units |
| Distribution | AL, IL, MD, NH, OH and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.