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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Abbott: NT2000iX RF Generators Recalled for Potential Inaccurate Failure Results

Agency Publication Date: November 2, 2023
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Summary

Abbott is recalling 34 units of the NT2000iX Radiofrequency (RF) Generator (Model REF RFG-NT-2000), a device used for lesioning during medical procedures. These specific generators were serviced using a tool that was out of tolerance, which may have resulted in inaccurate tests for potential capacitance failure. This means the device may not correctly detect internal component failures that could occur during use. Abbott has initiated this voluntary recall to ensure the safety and accuracy of the equipment used in patient care.

Risk

If the generator has an undetected capacitance failure, it could lead to inaccurate energy delivery or device malfunction during a medical procedure. This poses a potential risk of injury to patients or clinicians if the equipment does not perform as expected during a lesioning treatment.

What You Should Do

  1. Identify your device by checking the model and serial number on the generator. This recall affects Abbott NT2000iX Radiofrequency (RF) generators with model number REF RFG-NT-2000 and UDI/DI 05415067022417.
  2. Verify if your specific unit is one of the 34 affected 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, or 19197174.
  3. If you possess an affected device, contact your healthcare provider or Abbott directly for instructions regarding the inspection or servicing of your unit.
  4. Follow any specific instructions provided in the notification letter sent by Abbott to the facility where the device is located.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/servicing

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Abbott NT2000iX Radiofrequency (RF) generator
Model / REF:
REF RFG-NT-2000
UPC Codes:
05415067022417
Lot 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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93152
Status: Active
Manufacturer: Abbott
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 34 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.