Events

Recall of GE Centricity PACS RA1000 Workstation Software

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
    53462
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2010
  • Event Date Posted
    2009-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85563
  • 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
    Radiological Image Processing System - Product Code LLZ
  • Reason
    There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of ge centricity pacs ra1000 workstation software that may impact patient safety.
  • Action
    GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated September 23, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers, to the attention of the Hospital Risk Manager, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator, on 9/25/09. The letters advised the users of the patient safety issues associated with the use of GE Centricity PACS related to unintentionally adding new images to an approved exam; deletion of images from PACS if Cancel Checked or Cancel Selected is chosen in the CA Tool - Archive Queue; inadvertently getting two or more exams out of sync with the corresponding reports resulting in the RIS-IC reports being associated with the wrong patients exam; and when rejecting a duplicate image(s) from an unspecified exam that is still in the Arrived or Verified status, the duplicate image(s) is also rejected from the Dictated, Transcribed, or Completed status exam. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The 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. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issues and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.

Device

GE Centricity PACS RA1000 Workstation Software
  • Model / Serial
    Software versions 1.0.x, 2.0.x, 2.1.x, and 3.0.x.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
  • Product Description
    GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.
  • 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