Events

Recall of Device Recall GE Centricity PACSIW Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Healthcare It.

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
    55037
  • Event Risk Class
    Class 2
  • Event Number
    Z-1402-2010
  • Event Initiated Date
    2010-02-11
  • Event Date Posted
    2010-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89729
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    There is a potential safety issue associated with the use of ge centricity pacs-iw and pacs web diagnostic software when dragging-and-dropping images from the navigator causing flipping of the images that may impact patient safety.
  • Action
    GE Healthcare issued "Urgent Medical Device Correction" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. Accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479. For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.

Device

Device Recall GE Centricity PACSIW Software
  • Model / Serial
    Software version 3.7.3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom
  • Product Description
    GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || Device that receives, stores and communicates medical images and data from various imaging sources.
  • Manufacturer
    Ge Healthcare It

Manufacturer

Ge Healthcare It
  • Manufacturer Address
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA