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 093 10 11 000
Date submitted:	10/31/2011

Manufacturer:	GE Healthcare
Device Type:	GE CentricityTM Critical Care, Information System, Patient record
Description:	Information System, Patient record
Medical Device Identifier:	SP3 Patch C All versions are affected
Reason of Field Safety Corrective Action:	The user misinterpreted the digit grouping separator as decimal separator due not be aware of the difference between digit grouping and decimal separator and because the software accepted this as valid character a saved dose was 10 times higher than intended. The correct country specific decimal separator is taken by the system from a reference-table implemented in the software.
Remedy Action:	A Field Safety Notice will be sent out to all affected customers giving them instructions to follow, until the software release, in order to prevent this issue to occur. This issue will be remediated through a software release that will be implemented on the installed base via the Field Action FMI 85222.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh , (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	5A8B783E1C1B7
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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