CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Centricity Enterprise Archive recalled by Ge Healthcare It
Ge Healthcare It is recalling Centricity Enterprise Archive is a, distributed nationwide in the US. The recall was initiated on 16 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2739-2016
- FDA event ID
- 64761
- Recalling firm
- Ge Healthcare It, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2012
- FDA classified
- 6 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 16 Nov 2012 | Recall initiated by company | |
| 6 Sep 2016 | Classified by FDA | +1390 days |
| 14 Sep 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. 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 other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users 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-I profiles (published by IHE).
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
Which lots are affected?
Version: 3.0.x
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ge Healthcare It
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Centricity Laboratory Core Lab System 4.1 The Centricity recalled | GE Healthcare It | Device Malfunction | 6 states |
| Device | CLASS II | GE Centricity PACS Workstation recalled by GE Healthcare It | GE Healthcare It | Other | Nationwide |
| Device | CLASS II | Imagecast Pacs with Centricity Ris-ic versions prior recalled | Ge Healthcare It | Device Malfunction | Nationwide |
| Device | CLASS II | Centricity Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
| Device | CLASS III | The Centricity Laboratory System is intended to be recalled | GE Healthcare It | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |