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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 112 03 12 000
Date submitted: 3/31/2012
Manufacturer:DMX-Works Inc.
Device Type:Digital Motion X-ray System
Description:(DMX) is a fluoroscopic X-ray system which allows clinicians to view X-ray images of the body in real-time motion.
Medical Device Identifier:Serial no.: All, Lot/batch no.: All
Reason of Field Safety Corrective Action:It may pose a safety risks to patients and users
Remedy Action:Stop using the Digital Motion X-Ray System immediately.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:CA-2012-03-29-003
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments