FDA-Device2014-08-27Class II
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the br
Medtronic Neuromodulation
Hazard
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
Sold states
Distributed in the states of: MA, NC, OH, and TX.
Affected count
6
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2014Don't want to check this manually?
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