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NCAR Recall
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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
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.