Abbott NeuroTherm Radiofrequency Generator Recalled for Capacitor Failure
Abbott is recalling 318 NeuroTherm NT2000iX Radiofrequency Generators due to potential capacitor failure that may cause output loss or smoky odors.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for fire or smoke (charring/smoky odor) and loss of function, representing a risk of harm where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Abbott Laboratories Inc. (St Jude Medical) is recalling 318 units of the NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000. The recall is due to a potential capacitor failure that typically manifests as an inability to provide output on one or more channels. In some instances, users reported a charring or smoky odor or emission.
The affected devices were distributed in the United States and internationally, including Australia, Egypt, South Africa, Belgium, Colombia, the United Kingdom, Costa Rica, Israel, South Korea, Singapore, and Taiwan. The recall covers specific serial numbers listed in the agency's documentation.
Healthcare providers should stop using the affected devices and contact Abbott for instructions on repair or replacement. Patients who have undergone procedures using these devices should consult their healthcare provider if they have concerns about the procedure's outcome.
The recalled product
- Product
- NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
- Manufacturer
- Abbott Laboratories Inc. (St Jude Medical)
- Affected units
- 318
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 05415067022417: Serial Numbers: 18675078
- 18709738
- 18097502
- 18023105
- 18739462
- 18650501
- 18493702
- 18718469
- 18666645
- 18634334
- 18666647
- 18427317
- 18742999
- 18709732
- 18222185
- 18222187
- 18240730
- 18201200
- 18743003
- 18343825
Distribution
Distribution scope not specified by the agency.
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