Events

Recall of Centricity Enterprise Archive

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
    52858
  • Event Risk Class
    Class 2
  • Event Number
    Z-2316-2009
  • Event Initiated Date
    2009-08-14
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84174
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • Reason
    Software error: there is potential safety issue with centricity enterprise archive (ea) 3.0.X software where study split operations are not correctly replicated to a secondary 'shadow' archive.
  • Action
    GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated August 7, 2009 to the attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the potential safety issue and provided safety instructions to follow until the software is updated. Users were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Any questions should be directed to the Remote Online Center or the GE Customer Care Center at 1-800-437-1171.

Device

Centricity Enterprise Archive
  • Model / Serial
    Software versions 3.0, 3.0.1, 3.0.2, 3.0.3, 3.0.4, 3.0.5, 3.0.6 and 3.0.7
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Product Description
    Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images.
  • 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