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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 003 06 11 000
Date submitted: 6/4/2011
Manufacturer:GE Healthcare
Device Type:Positron Emission Tomography System
Description:Nuclear Medicine System, Positron Emission Tomography and
X-ray System, Diagnostic, Computed Tomography, Full-body
Medical Device Identifier:Discovery VCT, Discovery RX VCT, Discovery STE, Discovery RX and Discovery ST systems with Dimension console. Discovery ST systems without Dimension consoles are not affected.
Reason of Field Safety Corrective Action:Due to an issue in the system time adjustment feature, the system time can drift. If unchecked, or not connected to a network time server, system time can drift, impacting Standardized Uptake Value (SUV) measurements. A fifteen minute difference between system time and the dose calibrator clock impacts SUVs by 10%. Discovery ST systems without Dimension consoles are not affected. No injury has been reported related to this issue.
Remedy Action:GE Healthcare will correct all affected systems by providing a one time field service action at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh (01) 4600530
Report Source:NCMDR
Source Ref. Number:A78C4E6F41231
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: FMI_13704_FSN_English[1].pdf