Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
FDA device recall Z-0209-2024 · posted 2023-11-02 · Open, Classified
Recall details
- Recalling firm
- Abbott
- 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.
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- GXD
- Quantity affected
- 34 devices
- Distribution
- US, Taiwan, and Colombia
- Date initiated
- 2023-09-28
- Date posted
- 2023-11-02
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NT 2000 LESIONING GENERATOR (K111576) | Neuro Therm, Inc. | 2011-09-20 |