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Recall Observatory FDA recall evidence

Device 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).

Z-0833-2015

April 19, 2013

Class II

Product summary

Firm
Ge Healthcare It
Event
Event 64760
Status
Terminated
Classification
Class II
Quantity
115 units
Official record key
device-enforcement:Z-0833-2015

Official wording

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.

Code information: Centricity Enterprise Archive versions: 4.0.x

Distribution pattern: Nationwide Distribution including AZ, OH, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.