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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 100 11 18 000
Date submitted:	11/28/2018

Manufacturer:	AGFA Corp.
Device Type:	DX-D 600 X-ray system
Description:	Radiography x-ray imaging system
Medical Device Identifier:	This Safety Notice refers to your DR unit “DX-D 600” (DX-D 600 Automatic System, DX-D 600 Automatic Wall stand Only).
Reason of Field Safety Corrective Action:	The unit is equipped with safety measures so no movement may occur without user interaction. After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position. This issue only occurs with a specific combination of dedicated software versions with specific hardware board revisions.
Remedy Action:	Actions undertaken by Agfa: Soon Agfa or its representative will visit your site and install the latest revision of the hardware board, which will prevent a movement without user interaction. Recommended actions to be taken by you: If you notice an Overhead Tube Crane movement without user interaction, notify your Agfa Service contact at once.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	65D5FC19652B4
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	AGFA Healthcare NV.pdf

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