Events

Recall of Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare Integrated IT Solutions.

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
    49460
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2009
  • Event Date Posted
    2008-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73474
  • 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
    Perinatal Monitoring System - Product Code HGM
  • Reason
    Software anomalies in the alert and reminder feature could result in a delay of treatment. when attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
  • Action
    The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.

Device

Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder
  • Model / Serial
    software version 6.80.0 only with Alert and Reminder feature activated
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- state of Ohio.
  • Product Description
    GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 || Intended for use as a clinical data management system.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Manufacturer Address
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA