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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 125 05 18 000
Date submitted: 5/24/2018
Manufacturer:SIEMENS
Device Type:AXIOM Artis and Artis Zee Systems
Description:Stationary angiographic x-ray system, digital
Medical Device Identifier:AXIOM Artis and Artis Zee Systems with a specfic production lot of detector cooling units.
Reason of Field Safety Corrective Action:The Artis system may shut down suddenly due to a technical problem which affects the detector cooling unit. The problem occurs sporadically and might occur during an ongoing procedure.
Remedy Action:Siemens service organization will mitigate the Issue by replacing all affected cooling units. 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:958E2FCFEA30B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: SIEMENS.pdf