FDA recall Z-1549-2021

Abbott Laboratories Inc. (St Jude Medical) · Class II · device

Product

NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Reason for recall

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.

Distribution

US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN

Key facts

Status: Terminated
Initiation date: 2021-04-22
Report date: 2021-05-19
Termination date: 2023-02-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1549-2021