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.
Recall
- Recall Number
- Z-2316-2009
- Event Number
- 52858
- Firm
- GE Healthcare Integrated IT Solutions
- FEI Number
- 3004526608
- Product Code
- LMB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- August 14, 2009
- Posted
- September 24, 2009
- Terminated
- February 25, 2011
- Address
- 540 W Northwest Hwy, Barrington, IL, 60010-3051
Description
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.
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.
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.
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.
212 units