Recall Z-0373-2007 ยท LLZ System, Image Processing, Radiological
GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
| Date | Jan 25, 2007 (initiated Jan 12, 2007) |
| Status | Terminated |
| Reason | The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential. |
| Root cause | Other |
| Action | GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order |
| Quantity | 198 units |
| Distribution | Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom. |
| 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 |