Recall Z-0870-2009 ยท LMD System, Digital Image Communications, Radiological
GE Healthcare Integrated IT Solutions
Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
| Date | Jan 12, 2009 (initiated Dec 12, 2008) |
| Status | Terminated |
| Reason | Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. |
| Root cause | Software design |
| Action | GE Healthcare Integrated IT Solutions notified their Centricity Enterprise Web software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomalies resulting in patient safety issues involving a forced log off during an open session while using the Centricity Enterprise Web and measurements displayed in Centricity Enterprise Web will use the calibration provided by the original scanning modality. Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. The letter provided the users with safety |
| Quantity | 742 units |
| Distribution | Worldwide Distribution including USA and countries of Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway, Portu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.