Home / Recalls / GE Healthcare It / Z-2579-2016

Z-2579-2016 Class II Terminated

Recalled by GE Healthcare It — Barrington, IL

FDA device recall Z-2579-2016 was initiated by GE Healthcare It on November 15, 2012 and is designated Class II. Reason for recall: While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and h… The recall status is terminated (terminated December 13, 2017). Affected quantity: 498 units.

Recall Details

Product Type
Devices
Report Date
August 24, 2016
Initiation Date
November 15, 2012
Termination Date
December 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
498 units

Product Description

GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

Reason for Recall

While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.

Distribution Pattern

Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.

Code Information

Centricity PACS versions 3.1.1.x through 3.2.1.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)

FDA data resources