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.
Recall
- Recall Number
- Z-0116-2014
- Event Number
- 65471
- Firm
- GE Healthcare It
- FEI Number
- 3004526608
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- June 11, 2013
- Posted
- October 30, 2013
- Terminated
- June 10, 2016
- Address
- 540 W Northwest Hwy, Barrington, IL, 60010-3051
Description
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 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
URGENT MEDICAL DEVICE CORRECTION letters dated June 11, 2013 was mailed to all customers alerting them to these potential safety issues. The software was modified to correct these defects and a GE Healthcare service representative will contact each customer to make arrangements for installation of the new software version at no charge to the customer. Customers with concerns or questions about the market action can contact their local GE Healtchcare IT service representative or GE Healthcare's Remote Online Center - Customer Care Center at 1-800-437-1171.
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.
623 units