Device product
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Z-0225-2016
Product summary
- Firm
- GE Healthcare
- Event
- Event 72472
- Status
- Terminated
- Classification
- Class II
- Quantity
- Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units
- Official record key
device-enforcement:Z-0225-2016
Official wording
Reason: Inaccurate distance measurements with magnified projection X-ray images.
Code information: 2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT
Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
Derived failure modes
-
Unknown
Inaccurate distance measurements with magnified projection X-ray images.