| Class 2 Device Recall Centricity Enterprise Archive | |
Date Initiated by Firm | August 14, 2009 |
Date Posted | September 24, 2009 |
Recall Status1 |
Terminated 3 on February 25, 2011 |
Recall Number | Z-2316-2009 |
Recall Event ID |
52858 |
Product Classification |
Device, digital image storage, radiological - Product Code LMB
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Product | 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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
GE Healthcare Integrated IT Solutions 540 W Northwest Hwy Barrington IL 60010-3051
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For Additional Information Contact | GE Customer Care Center 800-437-1171 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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