Z-0456-2010

GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare...

Name: Z-0456-2010 GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare...
Creator: GE Healthcare Integrated IT Solutions
Published: 2009-09-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-09-25 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The... on 2009-09-25. The reason FDA records is "There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety". 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-0456-2010
Status: Terminated
Initiated: 2009-09-25
Posted: 2009-11-24
Terminated: 2012-05-25
Recalling firm: GE Healthcare
Product: GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation 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 are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated September 23, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers, to the attention of the Hospital Risk Manager, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator, on 9/25/09. The letters advised the users of the patient safety issues associated with the use of GE Centricity PACS related to unintentionally adding new images to an approved exam; deletion of images from PACS if Cancel Checked or Cancel Selected is chosen in the CA Tool - Archive Queue; inadvertently getting two or more exams out of sync with the corresponding reports resulting in the RIS-IC reports being associated with the wrong patients exam; and when rejecting a duplicate image(s) from an unspecified exam that is still in the Arrived or Verified status, the duplicate image(s) is also rejected from the Dictated, Transcribed, or Completed status exam. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issues 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: Software versions 1.0.x, 2.0.x, 2.1.x, and 3.0.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)