FDA-Device2023-11-01Class II
Centricity Universal Viewer Workflow Manager, Image processing radiological system
GE Healthcare
Hazard
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Sold states
Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.
Affected count
85 units
Manufactured in
500 W Monroe St, N/A, Chicago, IL, United States
Products
Centricity Universal Viewer Workflow Manager, Image processing radiological system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2024Don't want to check this manually?
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