Recall Z-2316-2009 ยท LMB Device, Digital Image Storage, Radiological
GE Healthcare Integrated IT Solutions
Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images.
| Date | Sep 24, 2009 (initiated Aug 14, 2009) |
| Status | Terminated |
| Reason | Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive. |
| Root cause | Software design |
| Action | GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated August 7, 2009 to the 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 potential safety issue and provided safety instructions to follow until the software is updated. Users were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Any questions should be directed to the Remote Online Center or the GE Customer Care Center at 1-800-437-1171. |
| Quantity | 212 units |
| Distribution | Worldwide Distribution -- United States, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.