Reported Dec 31, 2014 · Terminated
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices…
Ge Healthcare It
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ge Healthcare It · 540 W Northwest Hwy · Barrington, IL · 60010-3051
Is this the product you have?
- 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).
- Lot codes and dates
- Centricity Enterprise Archive versions4.0.x
- Amount recalled
- 115 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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