Z-1549-2021Class II

NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Name: Z-1549-2021 NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Creator: Abbott Laboratories Inc. (St Jude Medical)
Published: 2021-04-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-04-22 / Terminated

FDA source

Abbott Laboratories Inc. (St Jude Medical) began a recall of NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 on 2021-04-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1549-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-22
Posted: 2021-05-10
Terminated: 2023-02-02
Recalling firm: Abbott Medical
Product: NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Product code: GXD Generator, Lesion, Radiofrequency
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 root cause: Process change control
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.
Quantity in commerce: 318 units
Distribution: US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1549-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1549-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-10

Product code GXD

K111576Class IINt 2000 Lesioning GeneratorNeuro Therm, Inc. / cleared 2011-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)