FDA-Device2017-07-19Class II
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
GE Healthcare, LLC
Hazard
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Sold states
US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d'Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kenya Korea (Republic Of) Kuwait Latvia Lebanon Lithuania Malaysia Maldives Malta Mauritius Mexico Moldova Morocco Myanmar Netherlands New Zealand Nigeria Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe
Affected count
3,448 (334 US; 3,114 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2703-2017Don't want to check this manually?
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