Events

Recall of Device Recall GE Centricity PACS RA1000 Workstation

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
    37121
  • Event Risk Class
    Class 2
  • Event Number
    Z-0373-2007
  • Event Initiated Date
    2007-01-12
  • Event Date Posted
    2007-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49945
  • 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
    diagnostic image analysis - Product Code LLZ
  • Reason
    The centricity pacs ra1000 workstation software may manifest certain mammography image display problems only if the images were acquired through ge senographe versions 2000d, ds or essential.
  • Action
    GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.

Device

Device Recall GE Centricity PACS RA1000 Workstation
  • Model / Serial
    GE Centricity PACS RA1000 Workstation Software versions 2.1.X.X. and 3.0.X.X. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom.
  • Product Description
    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. 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