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
    50538
  • Event Risk Class
    Class 2
  • Event Number
    Z-0836-2009
  • Event Initiated Date
    2008-12-12
  • Event Date Posted
    2009-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75716
  • 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
    Picture archiving and communications system - Product Code LLZ
  • Reason
    There is a potential patient safety issue involving the use of the f12 keyboard approve & complete function. the issue may cause erroneous information to be added to a report when trying to approve and complete it.
  • Action
    GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomaly resulting in a patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. 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 414-918-4653.

Device

Device Recall GE Centricity PACS RA1000 Workstation
  • Model / Serial
    Software versions PACS 1.0CSR5/2.0CSR1 and all service packs
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and United Kingdom
  • Product Description
    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
  • 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