FDA recall Z-0209-2024

Abbott · Class II · device

Product

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

Reason for recall

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.

Distribution

US, Taiwan, and Colombia

Key facts

Status: Ongoing
Initiation date: 2023-09-28
Report date: 2023-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0209-2024