Z-0209-2024 Class II Ongoing
FDA device recall Z-0209-2024 was initiated by Abbott on Sep 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
- Nov 8, 2023
- Initiation Date
- Sep 28, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0209-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026