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Medtronic Neuromodulation recalls Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery
Recalled December 14, 2016 · FDA recall Z-0700-2017 · Medtronic Neuromodulation
Hazard
Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. Medtronic has determined all Rechargers manufactured starting in November 2014 (indicated by serial numbers beginning with NKA4 or NKU4 ) are more susceptible to this error state. · FDA Class II
Units
42,887
Sold at
Worldwide Distribution - US Nationwide including DC OUS: Canada and others.
Description
Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. Medtronic has determined all Rechargers manufactured starting in November 2014 (indicated by serial numbers beginning with NKA4 or NKU4 ) are more susceptible to this error state.
Product
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →