FDA-Device2020-11-11Class II
Flow Sensor Service Part, Catalog 2089610-001-S
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
4794 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Flow Sensor Service Part, Catalog 2089610-001-S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0315-2021Don't want to check this manually?
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