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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 003 10 15 000
Date submitted:	10/2/2015

Manufacturer:	Welch Allyn
Device Type:	KleenSpec Corded illumination System
Description:	illumination System
Medical Device Identifier:	Details on affected devices: Model: 78810, 78812, 78814, 78816, 79910, 79912, 79914 and 79916 Affected Devices: All KleenSpec® Corded Illumination Systems can be affected, regardless of lot.
Reason of Field Safety Corrective Action:	Welch Allyn has been made aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a C7 type of AC power cord (i.e. IEC 60320) instead of being correctly connected to the illuminator DC power cord connector.
Remedy Action:	Do Not connect the KleenSpec Corded Illuminator directly into AC line power cord. The AC line power cords do not have an integrated wall transformer. The KleenSpec Corded Illuminator should only be used with the power cord supplied with it and NOT any other power cord that may appear to fit the illuminator. Welch Allyn will shortly supply users with labels to affix to the two ends of the Kleen Spec® Corded Illumination System power cord connector to remind you to only connect the Welch Allyn llluminator with Welch Allyn corded wall transformer.
Athorized Representative/Importer/Distributor:	ABDULREHMAN AL GOSAIBI GTB
Report Source:	NCMDR
Source Ref. Number:	2291D7B0DC316
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Welch Allyn.pdf

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