Z-0833-2015 Class II Terminated
FDA device recall Z-0833-2015 was initiated by Ge Healthcare It on April 19, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 10, 2016). Affected quantity: 115 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- April 19, 2013
- Termination Date
- June 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 units
Product Description
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).
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.
Distribution Pattern
Nationwide Distribution including AZ, OH, WA.
Code Information
Centricity Enterprise Archive versions: 4.0.x