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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 028 09 18 000
Medical Device Identifier:
List number : 06P33
Serial Numbers : All
Reason of Field Safety Corrective Action:
Abbott Diagnostics has received the attached Urgent Field Safety Notice from Inpeco, the manufacturer of ACCELERATOR a3600. The transport mechanism component that allows the movement of the robot along the axes generates a magnetic field which at close distance may interfere with the pacemaker/implanted heart defibrillator functionality.
Refer to necessary action section in the attached Urgent Field Safety Notice.
Your Abbott representative will be contacting you to schedule time to place a new hazard label on the a3600.
Medical supplies & Services Co.Ltd Mediserv
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.