medical Class II Updated 2023-11-08

Abbott recalls Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-20

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: US, Taiwan, and Colombia
Lot/Code Info: 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
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