FDA-Device2021-12-01Class II
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
Medtronic Neuromodulation
Hazard
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
Sold states
US Nationwide, including PR. There was government distribution but no military distribution was identified.
Affected count
10 devices
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2022Don't want to check this manually?
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