Company: Medtronic Neuromodulation
Date of Enforcement Report 12/14/2016
Class lI:
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.
Recall Number Z-0700-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN on 12.3/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
42,887
DISTRIBUTION
Nationwide and Internationally.
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