Home / Recalls / Ge Healthcare It / Z-2739-2016

Z-2739-2016 Class II Terminated

Recalled by Ge Healthcare It — Barrington, IL

Recall Details

Product Type
Devices
Report Date
September 14, 2016
Initiation Date
November 16, 2012
Termination Date
January 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,379 units

Product Description

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).

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.

Distribution Pattern

Nationwide Distribution

Code Information

Version: 3.0.x

Other recalls by Ge Healthcare It

  • Z-0748-2014 Class II — Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation (August 26, 2013)
  • Z-0116-2014 Class II — The Centricity PACS Workstation is intended for use as a primary diagnostic and (June 11, 2013)
  • Z-0833-2015 Class II — Centricity Enterprise Archive is a software product for receiving, archiving and (April 19, 2013)
  • Z-0620-2014 Class II — The Centricity Laboratory System is intended to be an information system designe (March 12, 2013)
  • Z-0330-2014 Class II — The Centricity Laboratory System is intended to be an information system designe (March 12, 2013)
  • Z-0337-2014 Class II — Centricity Perinatal and Centricity Intensive Care is intended to be used in cli (March 11, 2013)
  • Z-2300-2016 Class II — Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 (February 18, 2013)
  • Z-1585-2013 Class II — The Centricity Laboratory System is intended to be an information system designe (November 20, 2012)
  • Z-0865-2014 Class III — The Centricity Laboratory System is intended to be an information system designe (November 20, 2012)
  • Z-2671-2016 Class II — Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is (November 20, 2012)