• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

  • Print
  • Share
  • E-mail

Event Detail

Event ID 65471
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare It
City Barrington
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-11
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. GE Centricity PACS Versions:, 3.2,,, 3.2.1, 3.2.2,,,, 3.2.6, 4.0, 4.0.1 Class II GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the synchronization between Nuance PowerScribe 360 and Centricity PACS RA1000 Workstation. 3) Interrupted workflow could break the synchronization between Agfa Talk and Centricity PACS RA1000 Workstation. 623 units Z-0116-2014