FDA-Device2023-11-08Class II
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Abbott
Hazard
Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
Sold states
US, Taiwan, and Colombia
Affected count
34 devices
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0209-2024Don't want to check this manually?
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