Events

Recall of Device Recall PatientNet

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

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
    28410
  • Event Risk Class
    Class 2
  • Event Number
    Z-0727-04
  • Event Initiated Date
    2004-02-27
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31796
  • 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, Network And Communication, Physiological Monitors - Product Code MSX
  • Reason
    Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
  • Action
    Consignees were notified via certified mail, return receipt requested, on Friday, February 27, 2004. GE Field service representatives will upgrade affected PatientNet Central Stations (RVS, IRVS, or Sitelink IRVS) to software version 2.01.

Device

Device Recall PatientNet

Manufacturer

General Electric Medical Systems Information Technology
  • Manufacturer Address
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Source
    USFDA