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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 092 01 13 000
Date submitted:	1/23/2013

Manufacturer:	GE Healthcare
Device Type:	Infant radiant warmers, Lullaby Warmers
Description:	Infant radiant warmers
Medical Device Identifier:	All Lullaby Warmers (Model # 2041599-001)
Reason of Field Safety Corrective Action:	If after fully assembling the Lullaby Warmer, it has been transported under rough conditions such as outdoors, in a truck, or over difficult/abrupt thresholds, there is a potential for the joint between the heater head and the support structure to break. If the breakage goes undetected, the head may fall on a patient resulting in a severe adverse patient outcome.
Remedy Action:	To minimize any safety risk associated with the Lullaby Warmer, stop using the unit immediately until the issue is corrected. A GE Healthcare representative will contact you to make arrangements to install the correction when it becomes available.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh, (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	60E603E06428D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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