Abbott Laboratories Inc. (St Jude Medical) Recall 87826
Description: NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Abbott Laboratories Inc. (St Jude Medical) Recall 87826 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1549-2021 |
Event ID | 87826 |
Event Description | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 |
Product Type | Devices |
Distribution | US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN |
Quantity | 318 units |
Recall 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. |
Device Classification | 20210519 |
Device 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, 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 |
Center Classification Date | 20210510 |
Recall Initiation Date | 20210422 |
Recalling Firm | Abbott Laboratories Inc. (St Jude Medical) |
Initial Notification | Letter |
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