Recall Z-2579-2016 ยท LLZ System, Image Processing, Radiological
GE Healthcare It
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface prov
| Date | Nov 15, 2012 |
| Status | Terminated |
| Reason | While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors. |
| Root cause | Software design |
| Action | GE sent an Urgent Medical Device Correction letter dated November 15, 2012. The software has been modified to correct these defects. The modified software was released and installed in user sites under GE Healthcare FMI #85196. |
| Quantity | 498 units |
| Distribution | Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, |
| 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 |