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 136 09 12 000
Date submitted:	9/16/2012

Manufacturer:	Philips Healthcare
Device Type:	HeartStart XL Defibrillator/Monitor Battery
Description:	Defibrillator/Monitor
Medical Device Identifier:	Units Affected: HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture.
Reason of Field Safety Corrective Action:	If the XL Defibrillator/Monitor (M4735A) is used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
Remedy Action:	Philips will Providing affected customers no charge replacement battery (s) as soon as new production is available. A Philips Healthcare representative will contact customers with affected battery(s) to arrange for replacement.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:	NCMDR
Source Ref. Number:	2329CD26981D7
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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