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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 054 03 13 000
Date submitted: 3/10/2013
Manufacturer:Siemens Medical Solutions
Device Type:Stationary angiographic x-ray system, digital
Description:X-ray system, digital
Medical Device Identifier:Software Artis: VC20x/VC21A/VD10x
Reason of Field Safety Corrective Action: Potential malfunction may occur randomly after system installation or software upgrade to Artis VC20x/VC21A/VD10x. If the operator has moved the system (stand or table) between DSA taken and DSA used as mask when executing the OGP roadmap in the DSA overlay mode, the image visualizing the vessel tree and the roadmap image visualizing devices such as a catheter may not be registered precisely when displayed on the live monitor.
Remedy Action: Until a software patch eliminating this problem is installed. the operator shall follow the instructions below: • The system (stand or table) is not to be moved between DSA taken and DSA used as mask when executing the OGP roadmap in the OSA overlay mode. (See attached)
Athorized Representative/Importer/Distributor:Siemens Medical Solutions, Riyadh, (01)277-8111
Report Source:NCMDR
Source Ref. Number:624773F39E2AD
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Medical Solutions.pdf