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.
This recall has been terminated (originally issued September 24, 2009).
- Recall Initiated
- August 14, 2009
- Posted
- September 24, 2009
- Terminated
- February 25, 2011
- Recall Number
- Z-2316-2009
- Quantity
- 212 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Software versions 3.0, 3.0.1, 3.0.2, 3.0.3, 3.0.4, 3.0.5, 3.0.6 and 3.0.7
Root Cause
Software design
Action Taken
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.