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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 028 09 18 000
Date submitted: 9/12/2018
Device Type:Accelerator a3600
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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:ED976D4C1F25C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott 2.pdf