PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 19, 2021 Initiated: April 22, 2021 #Z-1549-2021

Product Description

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.

Details

Units Affected
318 units
Distribution
US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000. Recalled by Abbott Laboratories Inc. (St Jude Medical). Units affected: 318 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1549-2021.