Recall Z-0456-2010 ยท LLZ System, Image Processing, Radiological
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.
| Date | Nov 24, 2009 (initiated Sep 25, 2009) |
| Status | Terminated |
| Reason | 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 | 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 - Arch |
| Quantity | 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, Por |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043415 | CENTRICITY PACS SYSTEM Ge Medical Systems Information Technologies, Jan 21, 2005 |