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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 095 06 18 000
Date submitted: 6/27/2018
Manufacturer:SIEMENS
Device Type:Artis Q/Pheno systems
Description:Stationary angiographic x-ray system, digital
Medical Device Identifier:Artis Q/Pheno systems and X-ray generator
Reason of Field Safety Corrective Action:In case of a short-circuit within the X-ray tube a leakage current might cause an overload of the X-ray generator. If this leakage current keeps undetected it may damage the generator by overheating.
Remedy Action:Siemens service organization will update all affected generators with a RCD (Residual Current Device) to detect leakage currents. The corrective action eliminates the root cause of the problem and prevents the failure from recurring.
Athorized Representative/Importer/Distributor:Siemens Medical Solutions
Report Source:NCMDR
Source Ref. Number:9AEA9CC6BD3A3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare.pdf