FDA-Device2023-10-11Class II
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Medtronic Neuromodulation
Hazard
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
Sold states
Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Affected count
2,408 devices
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2657-2023Don't want to check this manually?
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