GE Healthcare Integrated IT Solutions GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.

Recommended Action

Per FDA guidance

GE Healthcare IITS sent Urgent Safety Notice letters dated 5/9/08 to all customers who have the AW Suite Software Version 2.0, informing them of the incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta analysis protocol or customized protocols. The users were instructed not to use the aorta analysis protocol or the customized protocols for an aneurysm until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.