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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 148 10 18 000
Date submitted: 10/30/2018
Manufacturer:SIEMENS
Device Type:ARTIS zee Systems
Description:Stationary angiographic x-ray system, digital
Medical Device Identifier:ARTIS zee systems with a specific lot of X-ray tube cooling unit.
Reason of Field Safety Corrective Action:Due to a possible leakage of a cooling hose in the x-ray tube cooling unit, the loss of coolant can occur. This can have the consequence that the x-ray tube is no longer sufficiently cooled and the System will display the message "Tube hot have a break". In this case the system will block X-ray several minutes later to prevent further damages and displays the message "NO XRAY, TUBE TOO HOT". The problem occurs very sporadically and might occur during an ongoing procedure.
Remedy Action:Siemens service organization will replace the affected parts of the cooling units.
Athorized Representative/Importer/Distributor:Siemens Medical Solutions
Report Source:NCMDR
Source Ref. Number:E9763F543C22E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: SIEMENS.pdf