Home / Recalls / Ge Healthcare It / Z-0731-2014

Z-0731-2014 Class II Terminated

Recalled by Ge Healthcare It — Barrington, IL

FDA device recall Z-0731-2014 was initiated by Ge Healthcare It on September 15, 2012 and is designated Class II. Reason for recall: There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring fro… The recall status is terminated (terminated June 10, 2016). Affected quantity: 748 units.

Recall Details

Product Type
Devices
Report Date
January 22, 2014
Initiation Date
September 15, 2012
Termination Date
June 10, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
748 units

Product Description

Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use 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

There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once ter

Distribution Pattern

Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

Code Information

GE Centricity Software versions 3.X and higher and 4.X and higher

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-0865-2014 Class III — The Centricity Laboratory System is intended to be an information system designe (November 20, 2012)
  • Z-1585-2013 Class II — 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