FDA-Device2018-11-14Class II
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation 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
13
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0374-2019Don't want to check this manually?
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