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Terminated

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

FDA Recall Z-1549-2021 · Posted None

Recalling FirmAbbott Laboratories Inc. (St Jude Medical)
Recall StatusTerminated
Product CodeGXD
Date Initiated2021-04-22
Date Terminated2023-02-02
Product Quantity318 units

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.

Firm Action

The firm issued a medical device correction/service notice beginning on 04/22/2021. The notice discusses device failure and how to identify it. Should the failure present, then firm is requesting return of the device for servicing.

Root Cause

Process change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111576NT 2000 LESIONING GENERATORNeuro Therm, Inc. · 2011-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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