Z-2183-2008

GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic...

Name: Z-2183-2008 GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-06-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-06-11 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT... on 2008-06-11. The reason FDA records is "When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2183-2008
Status: Terminated
Initiated: 2008-06-11
Posted: 2008-09-16
Terminated: 2010-09-06
Recalling firm: GE Healthcare
Product: GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare IITS sent Product Safety Notification letters dated 6/11/08 to all customers who have the AW Suite Software Versions 2.0 and 2.0.1, informing them that if they also have Card IQ Xpress Pro or Plus, the AW Suite Card IQ software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label. The users were instructed not to make any clinical decisions based on a Card IQ Save State when a custom label has been ordered, and not to include leading or trailing blank characters (space bar) in the new branch name when customizing a Card IQ vessel analysis protocol 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.
Quantity in commerce: 207 units
Distribution: Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Malta, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland and Turkey
Product codes and lots: Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Module

Product code LLZ

K061372Class IICentricity Aw Suite OptionGe Healthcare Information Technologies / cleared 2006-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)