FDA Enforcement
Class II
Ongoing
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Recall: Z-0209-2024
·
Reported November 8, 2023
Enforcement
- Recall Number
- Z-0209-2024
- Event ID
- 93152
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2023
- Initiation Date
- September 28, 2023
- Classification Date
- November 2, 2023
- Address
- 5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States
Description
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.
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
Distribution
US, Taiwan, and Colombia
Quantity
34 devices