Z-1826-2008

GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions...

Name: Z-1826-2008 GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-05-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-05-06 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 on 2008-05-06. The reason FDA records is "A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis". 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-1826-2008
Status: Terminated
Initiated: 2008-05-06
Posted: 2008-09-02
Terminated: 2010-02-03
Recalling firm: GE Healthcare
Product: GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time 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: 177 units
Distribution: Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Malta, South Korea, Spain, Switzerland and United Kingdom.
Product codes and lots: GE Centricity PACS RA1000 Workstation software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X

Product code LLZ

K043415Class IICentricity Pacs SystemGe Medical Systems Information Technologies / cleared 2005-01-21

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)