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.
FDA Recall Z-2316-2009 · Posted 2009-09-24
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Recalling FirmGE Healthcare Integrated IT Solutions
Recall StatusTerminated
Product CodeLMB
Date Initiated2009-08-14
Date Terminated2011-02-25
Product Quantity212 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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