FDA-Device2021-05-12Class II
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
GE Healthcare, LLC
Hazard
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
Sold states
Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.
Affected count
112 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2021Don't want to check this manually?
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