Recall Z-1549-2009 ยท LLZ System, Image Processing, Radiological
GE Healthcare Integrated IT Solutions
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.
| Date | Jul 1, 2009 (initiated Apr 3, 2009) |
| Status | Terminated |
| Reason | 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 | 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 P |
| 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, Port |
| 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 |