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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Enterprise Archive 4.0

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  Class 2 Device Recall Centricity Enterprise Archive 4.0 see related information
Date Initiated by Firm April 19, 2013
Date Posted December 19, 2014
Recall Status1 Terminated 3 on June 10, 2016
Recall Number Z-0833-2015
Recall Event ID 64760
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. 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 that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are 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-1 profiles (published by IHE).
Code Information Centricity Enterprise Archive versions: 4.0.x
Recalling Firm/
Manufacturer		 Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Remote Online Center
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.
FDA Determined
Cause 2		 Software design
Action General Electric sent an Urgent Medical Device Correction letter dated April 19, 2013, to all affected customers. The letter instructs customers to ensure that Enterprise Archive partitions have enough free space available, in particular the cache disk should have at least 10% free space available. This could be facilitated by setting appropriate disk limits and watermarks on the individual libraries in Enterprise Archive. In case the disks are not being purged to the configured watermarks and the cache disk is almost full, customers are requested to contact their local GE service person. A permanent product correction will be provided to all customers under FMI85209R. Customers with questions were instructed to contact their local Sales/Service Representative. Also the Remote Online Center (ROC) Customer Care can be reached at 1-800-437-1171.
Quantity in Commerce 115 units
Distribution Nationwide Distribution including AZ, OH, WA.
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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