FDA-Device2021-05-12Class II
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.
Medtronic Neuromodulation
Hazard
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Sold states
Worldwide distribution.
Affected count
79,616 units
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2021Don't want to check this manually?
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