Recall Z-1549-2021— Abbott Laboratories Inc. (St Jude Medical)

Name: FDA recall Z-1549-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-22

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories Inc. (St Jude Medical), initiated 2021-04-22, terminated 2023-02-02. It names one FDA 510(k) clearance: K111576. Product: NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000. Reason: 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..

Recalling firm: Abbott Laboratories Inc. (St Jude Medical)
Classification: Class II
Status: Terminated
Initiated: 2021-04-22
Terminated: 2023-02-02
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K111576 — NT 2000 LESIONING GENERATORNeuro Therm, Inc.·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.