FDAClass IINovember 8, 2023

Abbott NT2000iX Radiofrequency recall

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

Why was Abbott NT2000iX Radiofrequency recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 05415067022417, serial numbers: 16930509, 16983330, 17583407, 17634837, 17783928, 17783930, 17905961, 17928413, 17954521, 17991999, 18047384, 18493711, 18522937, 18675068, 18690920, 18709734, 18742997, 2475-12, 2504-12, 2547-13, 2885-14, 3003-14, 3278-15, 3450-15, 3550-15, 17942357, 18003310, 18102335, 18132017, 18132092, 18657521, 18666647, 19182119, 19197174

Product
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Recalling firm
Abbott
Quantity
34 devices
Distribution
US, Taiwan, and Colombia
Recall date
November 8, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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