FDA Recall
Open, Classified
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Recall: Z-0209-2024
·
Initiated September 28, 2023
Recall
- Recall Number
- Z-0209-2024
- Event Number
- 93152
- Firm
- Abbott
- FEI Number
- 3005334138
- Product Code
- GXD
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- September 28, 2023
- Posted
- November 2, 2023
- Address
- 5050 Nathan Ln N, Plymouth, MN, 55442-3209
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.
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.
Distribution
US, Taiwan, and Colombia
Quantity
34 devices