High FDA (Devices)·Z-1549-2021·Announced 2021-05-19

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.

What this means for you

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)
Category: Medical Device — Radiofrequency Generator
Hazard: fire
smoke-emission
device-failure
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.

Same manufacturer · Abbott Laboratories Inc. (St Jude Medical)

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