Z-1549-2009

GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT...

Name: Z-1549-2009 GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT...
Creator: GE Healthcare Integrated IT Solutions
Published: 2009-04-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-04-03 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is... on 2009-04-03. The reason FDA records is "There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images". 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-1549-2009
Status: Terminated
Initiated: 2009-04-03
Posted: 2009-07-01
Terminated: 2012-05-25
Recalling firm: GE Healthcare
Product: GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare Integrated IT Solutions sent an "Urgent Medical Device Correction" letter dated April 2, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers with attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the patient safety issue associated with the affected device and provided safety instructions to follow until the software is updated. User were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issue and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.
Quantity in commerce: 1,188 units
Distribution: Worldwide Distribution - United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
Product codes and lots: Centricity PACS software versions 2.1.X and 3.0.X and Centricity PACS versions 1.0.X and 2.0.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)