Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
- Company
- Abbott
- Recall Initiated
- September 28, 2023
- Posted
- November 2, 2023
- Recall Number
- Z-0209-2024
- Quantity
- 34 devices
- Firm Location
- Plymouth, MN
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
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
Root Cause
Process change control
Action Taken
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.