FDA Medical Device Recalls (openFDA)
Abbott: Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
- Recall number
- Z-0209-2024
- Recalling firm
- Abbott
- Product
- Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
- Status
- Open, Classified
- Initiated
- 2023-09-28
- Posted
- 2023-11-02
- Terminated
- not on file
- 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.
- Root cause
- Process change control
- Action
- Abbott issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/28/2023 via FedEx 2nd day delivery. The notice explained the problem, risk, and requested return of the device for inspection. Those devices which pass, will be returned. Should your device(s) fail the inspection, your local Abbott Representative can advise the consignee of alternate commercially available products.
- Quantity
- 34 devices
- Distribution
- US, Taiwan, and Colombia
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K111576"]
- PMA numbers
- not on file
- Product code
- GXD
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28