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 083 10 14 000
Date submitted:	10/21/2014

Manufacturer:	Mortara Instrument, Inc.
Device Type:	Mortara Surveyor S12 and Surveyor S19 Patient Monitors
Description:	Patient Monitor
Medical Device Identifier:	Product Name : SURVEYOR Mortara Part Number : SUR12-BCF-AXXAD Device Serial Number : 114170207572 Product Name : SURVEYOR Mortara Part Number : SUR19-BCF-AXXAC Device Serial Number : 114170207577
Reason of Field Safety Corrective Action:	A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors.
Remedy Action:	A correction has been developed to eliminate the potential risk. The correction replaces the original battery cover with a new design incorporating a barrier that prevents mounting screws from penetrating into the battery compartment.
Athorized Representative/Importer/Distributor:	Saudi Health Services Co. Ltd.
Report Source:	NCMDR
Source Ref. Number:	8EB7F7CCFB403
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Mortara .pdf

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