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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 098 12 17 000
Date submitted: 12/25/2017
Manufacturer:Medtronic
Device Type:Signia Power Handle
Description:Motorized cutting stapler handpiece
Medical Device Identifier:All handles manufactured between January 2017 and October 2017

Serial Numbers: Multiple
Reason of Field Safety Corrective Action:Medtronic is issuing a notification following reports that the Signia Power Handle may shut down unexpectedly during use.
Remedy Action:Medtronic is advising users that a software upgrade will be implemented as a permanent correction.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:7C262BE2081B7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic (Signia power handles ).pdf