Recall Z-1549-2021
Abbott Laboratories Inc. (St Jude Medical) · initiated April 22, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Codes / 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…
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: Process change control
Action taken
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.
Details
- Recall number
- Z-1549-2021
- Initiated
- April 22, 2021
- Terminated
- February 2, 2023
- Product code
- GXD – Generator, Lesion, Radiofrequency
- Quantity
- 318 units
- Distribution
- US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN