Food, drugs, devices › Ge Healthcare It
Device recall: Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices
Ge Healthcare It (Barrington, IL) initiated this device recall on 19 Apr 2013; FDA lists 1 product record under event 64760, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 10 Jun 2016. Initiation: voluntary: firm initiated. Ge Healthcare It has 17 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ge Healthcare It, Barrington, IL.
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
"Nationwide Distribution including AZ, OH, WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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… | 115 units | Class II | Terminated | 31 Dec 2014 |
Context
Other enforcement events for Ge Healthcare It
All 17 events for Ge Healthcare It
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including AZ, OH, WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.