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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott NeuroTherm NT2000 Lesion Generator

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  Class 2 Device Recall Abbott NeuroTherm NT2000 Lesion Generator see related information
Date Initiated by Firm September 28, 2023
Date Posted November 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-0209-2024
Recall Event ID 93152
510(K)Number K111576  
Product Classification Generator, lesion, radiofrequency - Product Code GXD
Product Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Code Information 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, 2547-13, 2885-14, 3003-14, 3278-15, 3450-15, 3550-15, 17942357, 18003310, 18102335, 18132017, 18132092, 18657521, 18666647, 19182119, 19197174
Recalling Firm/
Manufacturer		 Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Shelley Lange
651-756-4091
Manufacturer Reason
for Recall		 Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
FDA Determined
Cause 2		 Process change control
Action Abbott issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/28/2023 via FedEx 2nd day delivery. The notice explained the problem, risk, and requested return of the device for inspection. Those devices which pass, will be returned. Should your device(s) fail the inspection, your local Abbott Representative can advise the consignee of alternate commercially available products.
Quantity in Commerce 34 devices
Distribution US, Taiwan, and Colombia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GXD and Original Applicant = NEUROTHERM, INC.
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