FDA Recall
Terminated
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Recall: Z-1549-2021
·
Initiated April 22, 2021
Recall
- Recall Number
- Z-1549-2021
- Event Number
- 87826
- Firm
- Abbott Laboratories Inc. (St Jude Medical)
- FEI Number
- 1000139754
- Product Code
- GXD
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- April 22, 2021
- Terminated
- February 2, 2023
- Address
- 1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789
Description
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Reason
Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
Action
The firm issued a medical device correction/service notice beginning on 04/22/2021. The notice discusses device failure and how to identify it. Should the failure present, then firm is requesting return of the device for servicing.
Distribution
US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
Quantity
318 units