Z-2739-2016Class II

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data...

Name: Z-2739-2016 Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data...
Creator: Ge Healthcare It
Published: 2012-11-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-11-16 / Terminated / root cause: software

FDA source

Ge Healthcare It began a recall of Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and... on 2012-11-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2739-2016
Classification: Class II
Status: Terminated
Initiated: 2012-11-16
Posted: 2016-09-06
Terminated: 2017-01-11
Recalling firm: GE Healthcare
Product: 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).
Product code: LMB Device, Digital Image Storage, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: URGENT MEDICAL DEVICE CORRECTION letters dated November 16, 2012 and April 19, 2013, were sent to all affected customers.The letters requested that customers verify that all Enterprise Archive partitions have enough free space available and that the cache disk has at least 10% free space available. The letters further requested that customers whose disks are not being purged to the configured watermarks and the cache disk is almost full to contact their local GE service person. A permanent product correction (Service Pack 12 and release notes) will be provided by GE Healthcare IT. Customers with questions can contact their GE service representative or the GE Healthcare IT Remote Online Center Customer Care Center at 1-800-437-1171.
Quantity in commerce: 1,379 units
Distribution: Nationwide Distribution
Product codes and lots: Version: 3.0.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2739-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2739-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06

Product code LMB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)