FDA-Device2018-11-14Class II

Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

GE Healthcare, LLC
Hazard

Synchronization failure

Sold states
CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
Affected count
73
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0375-2019

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