Events

Recall of Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision

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
    49459
  • Event Risk Class
    Class 2
  • Event Number
    Z-0112-2009
  • Event Date Posted
    2008-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73473
  • 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
    On the i&o; chart, the in, out and net fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.
  • Action
    GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.

Device

Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision
  • Model / Serial
    software version 6.70.6 of the Centricity Perinatal clinical information system
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision 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
  • 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