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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 017 10 17 000
Date submitted:	10/2/2017

Manufacturer:	Mobius Imaging, LLC
Device Type:	AIRO Mobile CT Scanner.
Description:	CT Scanner
Medical Device Identifier:	AIRO Mobile CT Scanner (model# MobiCT-32) All Airo systems
Reason of Field Safety Corrective Action:	Mobius Imaging believes, due to an issue with the configuration settings of the tilt-drive motion controller, if a tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended tilt motion of gantry while AIRO system is homing the axis at startup or preparing for a scan. Since the AIRO is not currently monitoring for intermittent connections or broken tilt-drive motor wires, if a wire breaks or the signal becomes intermittent the tilt-drive motor would not get the correct feedback and the motor could behave unpredictably.
Remedy Action:	Due to the risk of unintended (tilting) motion of the gantry, Mobius Imaging is advising all customers to discontinue using the AIRO until the tilt drive motion firmware has been updated on their system.
Athorized Representative/Importer/Distributor:	Al-Jeel Medical & Trading Co. LTD
Report Source:	NCMDR
Source Ref. Number:	C5438EEF0C291
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Mobius Imaging, LLC.pdf

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