Home / Recalls / Ge Healthcare It / Z-0833-2015

Z-0833-2015 Class II Terminated

Recalled by Ge Healthcare It — Barrington, IL

Recall Details

Product Type
Devices
Report Date
December 31, 2014
Initiation Date
April 19, 2013
Termination Date
June 10, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
115 units

Product Description

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).

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.

Distribution Pattern

Nationwide Distribution including AZ, OH, WA.

Code Information

Centricity Enterprise Archive versions: 4.0.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-0330-2014 Class II — The Centricity Laboratory System is intended to be an information system designe (March 12, 2013)
  • Z-0620-2014 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)
  • Z-2739-2016 Class II — Centricity Enterprise Archive is a software product for receiving, archiving and (November 16, 2012)