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Medtronic Neuromodulation recalls Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain
Recalled December 23, 2020 · FDA recall Z-0612-2021 · Medtronic Neuromodulation
Hazard
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. · FDA Class II
Units
12 devices
Sold at
US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Description
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Product
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →