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
    50758
  • Event Risk Class
    Class 2
  • Event Number
    Z-0969-2009
  • Event Initiated Date
    2009-01-12
  • Event Date Posted
    2009-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76983
  • 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
    If a user site created a custom default display protocol (ddp) to display the current exam versus the historical exam and the user-defined ddp fails, the system displays the exams using a ge default hanging protocol. this may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.
  • Action
    GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 1/12/09 of the software anomaly resulting in a patient safety issue involving Default Display Protocols. The issue may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars. 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.

Device

Device Recall GE Centricity PACS RA1000 Workstation
  • Model / Serial
    All software versions
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Bermuda, Mexico, Ecuador, Chile, and Brazil
  • Product Description
    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. 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