Z-1825-2008

GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for...

Name: Z-1825-2008 GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-05-09
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-05-09 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of 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... on 2008-05-09. The reason FDA records is "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...". 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-1825-2008
Status: Terminated
Initiated: 2008-05-09
Posted: 2008-09-02
Terminated: 2010-09-24
Recalling firm: GE Healthcare
Product: 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
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
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: software version 2.0

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)