FDAFDA · Food and drugs·Recall number Z-0833-2015
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).
Published December 31, 2014 · Recall initiated: April 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ge Healthcare It
- Distributor
- Nationwide Distribution including AZ, OH, WA.
- Lot
- Centricity Enterprise Archive versions: 4.0.x
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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