Recall Z-0833-2015
Ge Healthcare It · initiated April 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Centricity Enterprise Archive versions: 4.0.x
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: Software design
Action taken
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.
Details
- Recall number
- Z-0833-2015
- Initiated
- April 19, 2013
- Posted by FDA
- December 19, 2014
- Terminated
- June 10, 2016
- Product code
- LMB – Device, Digital Image Storage, Radiological
- Quantity
- 115 units
- Distribution
- Nationwide Distribution including AZ, OH, WA.
- Recalling firm
- Ge Healthcare It, Barrington, IL