GE Healthcare Integrated IT Solutions 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.