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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Enterprise Archive

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  Class 2 Device Recall Centricity Enterprise Archive see related information
Date Initiated by Firm November 16, 2012
Date Posted September 06, 2016
Recall Status1 Terminated 3 on January 11, 2017
Recall Number Z-2739-2016
Recall Event ID 64761
Product Classification Device, digital image storage, radiological - Product Code LMB
Product Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).
Code Information Version: 3.0.x
Recalling Firm/
Manufacturer		 Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact Remote Online Center Customer Care
800-437-1171
Manufacturer Reason
for Recall		 There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
FDA Determined
Cause 2		 Software design
Action URGENT MEDICAL DEVICE CORRECTION letters dated November 16, 2012 and April 19, 2013, were sent to all affected customers.The letters requested that customers verify that all Enterprise Archive partitions have enough free space available and that the cache disk has at least 10% free space available. The letters further requested that customers whose disks are not being purged to the configured watermarks and the cache disk is almost full to contact their local GE service person. A permanent product correction (Service Pack 12 and release notes) will be provided by GE Healthcare IT. Customers with questions can contact their GE service representative or the GE Healthcare IT Remote Online Center Customer Care Center at 1-800-437-1171.
Quantity in Commerce 1,379 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
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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