Home / Recalls / GE Healthcare It / Z-2671-2016

Z-2671-2016 Class II Terminated

Recalled by GE Healthcare It — Barrington, IL

Recall Details

Product Type
Devices
Report Date
September 7, 2016
Initiation Date
November 20, 2012
Termination Date
December 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17

Product Description

Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.

Reason for Recall

The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.

Distribution Pattern

Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.

Code Information

Versions 4.1, 4.0, 3.3.2 & 3.3Almp

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-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-2739-2016 Class II — Centricity Enterprise Archive is a software product for receiving, archiving and (November 16, 2012)