FDA Medical Device Recalls (openFDA)
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 number
- Z-0821-06
- Recalling firm
- LMS Medical Systems Ltd
- 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.
- Status
- Terminated
- Initiated
- 2005-01-11
- Posted
- 2006-04-27
- Terminated
- 2006-06-27
- 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
- Lot, serial or model codes
- Software version 02.09.01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 3002687025
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28