Events

Recall of Device Recall CALM perinatal monitoring system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LMS Medical Systems Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35138
  • Event Risk Class
    Class 2
  • Event Number
    Z-0821-06
  • Event Initiated Date
    2005-01-11
  • Event Date Posted
    2006-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45398
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Monitoring, Perinatal - Product Code HGM
  • 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.

Device

Device Recall CALM perinatal monitoring system
  • Model / Serial
    Software version 02.09.01
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, IL, MD, NH, OH and Canada
  • Product 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.
  • Manufacturer
    LMS Medical Systems Ltd

Manufacturer

LMS Medical Systems Ltd
  • Manufacturer Address
    LMS Medical Systems Ltd, 5252 De Maisonneuve, West, Suite 314, Montreal Canada
  • Source
    USFDA