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FDA (Device enforcement)Recalled 2021-04-22closedclass ii

Abbott Laboratories Inc. (St Jude Medical): NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Is my product affected?

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

  • UPC 05415067022417

Check against the official notice below — it lists the full affected range.

What happened

Abbott Laboratories is recalling the NeuroTherm NT2000iX Radiofrequency (RF) Generator due to a potential capacitor failure. The defect typically prevents the device from providing output on one or more channels. Some users have reported charring, smoky odors, or emissions from affected units. A total of 318 units with specific serial numbers have been identified as affected and were distributed in the United States and multiple international locations including Australia, Egypt, South Africa, Belgium, Colombia, the United Kingdom, Costa Rica, Israel, South Korea, Singapore, and Taiwan.

The recall notice does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN Quantity: 318 units Lot/code info: 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, 1826

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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