FDA-Device2020-11-11Class II
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
GE Healthcare, LLC
Hazard
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Sold states
U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom
Affected count
37 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2021Don't want to check this manually?
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