SFDA National Center for Medical Devices Reporting

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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 002 07 17 000
Date submitted:	7/3/2017

Manufacturer:	National Biological Corp
Device Type:	Hand Foot II
Description:	Light, ultraviolet, dermatological
Medical Device Identifier:	Model : UVB-138 Serial Number: 39869
Reason of Field Safety Corrective Action:	National Biological Corporation has received reports indicating that certain Hand Foot II (Model UVB-138) devices may have been shipped with a timer that doesn't function correctly. If the lamps turn on when the key is turned on the device is wired incorrectly.
Remedy Action:	National Biological Corporation has initiated a voluntary recall to replace any Hand Foot II devices (UVB-138) in the field
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCMDR
Source Ref. Number:	22934202FE1F7
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	National Biological.pdf

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