FDA-Device2021-05-19Class II
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Abbott Laboratories Inc. (St Jude Medical)
Hazard
Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
Sold states
US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
Affected count
318 units
Manufactured in
1 Saint Jude Medical Dr, Saint Paul, MN, United States
Products
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1549-2021Don't want to check this manually?
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