CLASS II Device recall · Reported 31 Dec 2014 · 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 19 Apr 2013 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-0833-2015
- FDA event ID
- 64760
- Recalling firm
- Ge Healthcare It, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2013
- FDA classified
- 19 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 19 Apr 2013 | Recall initiated by company | |
| 19 Dec 2014 | Classified by FDA | +609 days |
| 31 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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. 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).
Where it was distributed
Nationwide Distribution including AZ, OH, WA.
Questions about this recall
Why was it 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.
Which lots are affected?
Centricity Enterprise Archive versions: 4.0.x
Where was it sold?
Nationwide Distribution including AZ, OH, WA.
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 Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
| 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 III | The Centricity Laboratory System is intended to be recalled | GE Healthcare It | Device Malfunction | Nationwide |
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