Z-0209-2024 Class II Ongoing
FDA device recall Z-0209-2024 was initiated by Abbott on September 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 34 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- September 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 devices
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.
Distribution Pattern
US, Taiwan, and Colombia
Code Information
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