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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 126 10 16 000
Date submitted: 10/19/2016
Manufacturer:Medtronic SA
Device Type:Meddtronic Model 37751 Recharger included in Model 37651 Charging System
Description:Neuromuscular electrical stimulation system programmer, Battery charger
Medical Device Identifier:Model 37651, 37754 and 97754 (containing the model 37751 recharger)
Reason of Field Safety Corrective Action:Medtronic has identified an increased number of complaints from customers involving reports of Rechargers that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds.
Remedy Action:Please check out the recommendations in the attached FSN.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:7E665AF6A52D9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc..pdf