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U.S. Department of Health and Human Services

Class 2 Device Recall NeuroTherm NT2000iX Radiofrequency (RF) Generator

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 Class 2 Device Recall NeuroTherm NT2000iX Radiofrequency (RF) Generatorsee related information
Date Initiated by FirmApril 22, 2021
Create DateMay 10, 2021
Recall Status1 Terminated 3 on February 02, 2023
Recall NumberZ-1549-2021
Recall Event ID 87826
510(K)NumberK111576 
Product Classification Generator, lesion, radiofrequency - Product Code GXD
ProductNeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Code Information UDI 05415067022417: Serial Numbers: 18675078, 18709738, 18097502, 18023105, 18739462, 18650501, 18493702, 18718469, 18666645, 18634334, 18666647, 18427317, 18742999, 18709732, 18222185, 18222187, 18240730, 18201200, 18743003, 18343825, 18088294, 18201198, 18222190, 18240731, 17991994, 18132016, 18500164, 18522935, 18659497, 18750318, 18854584, 18718473, 18873320, 18240735, 18102325, 18648497, 18666643, 18666646, 18657521, 17991999, 18313159, 18614034, 18721060, 18493705, 18493709, 18610701, 18302046, 18192751, 18132012, 18222188, 18240728, 18718472, 18500167, 18132008, 18493711, 18313153, 17905956, 18060073, 18132011, 18102323, 18014268, 18014258, 18343824, 18240733, 18180086, 18675069, 18060017, 18060067, 18060071, 17964784, 18427318, 18648518, 18675068, 18648648, 18192752, 18709733, 18709734, 18302042, 18265068, 18659496, 18192753, 18192756, 18222183, 18522719, 18705743, 18522937, 18644839, 18873319, 18102324, 18088297, 18659489, 18706571, 18192754, 18622842, 18240729, 18180085, 18659495, 18187525, 18192750, 18115250, 18714394, 18666648, 18070518, 18072514, 18180082, 18634336, 18699641, 18854582, 18522709, 18704516, 18493701, 18716594, 18709741, 18873321, 18302048, 18644838, 18699645, 18102337, 18555754, 18743000, 18690921, 18180088, 18657520, 18522715, 18343821, 18201195, 18648650, 18522714, 18265071, 18709739, 18709735, 18023104, 18313165, 18070527, 18648652, 18650503, 18265072, 18666650, 18634337, 18313157, 18533473, 18648647, 18705742, 18644824, 18493707, 18699643, 18265070, 18343819, 17905963, 18070525, 18750319, 18343820, 18343823, 18650500, 17991997, 18701492, 18742994, 18014262, 18709742, 18854581, 18427321, 18659494, 18659493, 18644840, 18500166, 18533504, 18180083, 18427319, 18648008, 18648578, 18690926, 18657519, 18014259, 18014254, 18132092, 18302043, 18132014, 18003308, 18003311, 18003313, 18014255, 18014269, 18659490, 18047384, 18088295, 18014267, 18038591, 18023107, 18003310, 18014261, 18648619, 18648653, 18648655, 18102335, 18265069, 18854583, 18222191, 18014270, 18014271, 18690920, 18302047, 18696583, 18522716, 18427320, 18265066, 18302041, 18699642, 18192749, 18192755, 18675070, 18675076, 17860513, 17942355, 17959675, 17959676, 17959677, 17981234, 17981235, 18003314, 18003325, 18014272, 17860514, 17860515, 17905959, 17905962, 18187528, 18892887, 17905965, 17863602, 18302049, 18500165, 17856739, 18115251, 17856738, 17903459, 18115245, 18115246, 18126612, 18126613, 18500161, 17865145, 17856737, 18187529, 17981236, 17981233, 18132007, 18699646, 18180087, 18699640 
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc. (St Jude Medical)
1 Saint Jude Medical Dr
Saint Paul MN 55117-1789
For Additional Information ContactMr. Brent Tippen
512-286-4217
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process change control
ActionThe 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.
Quantity in Commerce318 units
DistributionUS and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GXD
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