Recall Z-0833-2015— Ge Healthcare It
Class II · Terminated
Class II FDA medical device recall by Ge Healthcare It, initiated 2013-04-19, terminated 2016-06-10. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: 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..
- Recalling firm
- Ge Healthcare It
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-19
- Terminated
- 2016-06-10
- Firm location
- Barrington, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.