Z-0833-2015Class II

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

Name: Z-0833-2015 Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data...
Creator: Ge Healthcare It
Published: 2013-04-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-04-19 / 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. DICOM devices (e..g. modalities, workstations)... on 2013-04-19. FDA classified it as Class II and gives the reason 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". 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-0833-2015
Classification: Class II
Status: Terminated
Initiated: 2013-04-19
Posted: 2014-12-19
Terminated: 2016-06-10
Recalling firm: GE Healthcare
Product: 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).
Product code: LMB Device, Digital Image Storage, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: General Electric sent an Urgent Medical Device Correction letter dated April 19, 2013, to all affected customers. The letter instructs customers to ensure that Enterprise Archive partitions have enough free space available, in particular the cache disk should have at least 10% free space available. This could be facilitated by setting appropriate disk limits and watermarks on the individual libraries in Enterprise Archive. In case the disks are not being purged to the configured watermarks and the cache disk is almost full, customers are requested to contact their local GE service person. A permanent product correction will be provided to all customers under FMI85209R. Customers with questions were instructed to contact their local Sales/Service Representative. Also the Remote Online Center (ROC) Customer Care can be reached at 1-800-437-1171.
Quantity in commerce: 115 units
Distribution: Nationwide Distribution including AZ, OH, WA.
Product codes and lots: Centricity Enterprise Archive versions: 4.0.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0833-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0833-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-19

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)