Recall Z-0209-2024— Abbott

Name: FDA recall Z-0209-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-28

Class II · Ongoing

Class II FDA medical device recall by Abbott, initiated 2023-09-28. It names one FDA 510(k) clearance: K111576. Product: Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator. Reason: 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..

Recalling firm: Abbott
Classification: Class II
Status: Ongoing
Initiated: 2023-09-28
Firm location: Plymouth, 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

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.

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