Z-0821-06

CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal...

Name: Z-0821-06 CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal...
Creator: LMS Medical Systems Ltd
Published: 2005-01-11
License: https://open.fda.gov/license/

PeriGen Solutions Ltd. / initiated 2005-01-11 / Terminated / root cause: software

FDA source

LMS Medical Systems Ltd began a recall of 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... on 2005-01-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0821-06
Status: Terminated
Initiated: 2005-01-11
Posted: 2006-04-27
Terminated: 2006-06-27
Recalling firm: PeriGen Solutions 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.
Product code: HGM System, Monitoring, Perinatal
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
Root cause tag: software
FDA 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 in commerce: 8 units
Distribution: AL, IL, MD, NH, OH and Canada
Product codes and lots: Software version 02.09.01

Product code HGM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)