FDA-Device2021-09-29Class II
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
GE Healthcare, LLC
Hazard
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Sold states
AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.
Affected count
392 (219 US; 173 OUS) all products
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2502-2021Don't want to check this manually?
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