Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool
Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential inaccuracy in measurement results from an out-of-tolerance servicing tool. No direct patient harm has been reported, making this a moderate-level precautionary recall.
Plain-English summary
Abbott is recalling 34 NT2000iX Radiofrequency (RF) generators, model RFG-NT-2000, used for lesioning procedures. These devices were serviced using a calibration tool that was subsequently found to be out of tolerance. As a result, the servicing may not have provided accurate measurement results for potential capacitance failures.
The affected devices were distributed in the United States, Taiwan, and Colombia. Affected units are identified by the UDI/DI 05415067022417 and associated serial numbers available from Abbott.
Clinicians and facility managers with affected equipment should contact Abbott for additional information and guidance regarding their devices.
The recalled product
- Product
- Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
- Manufacturer
- Abbott
- Affected units
- 34
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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