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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 086 03 11 000
Date submitted: 3/21/2011
Manufacturer:Ziehm Imaging GmbH
Device Type:Various Mobile X-Ray Systems
Description:Radiographic/Fluoroscopic Units, Mobile
Medical Device Identifier:Type KF21 Double Footswitches used with the following C-Arm X-Ray Systems: (1) Compact, (2) Solo, (3) Vision, (4) Vision FD, (5) Vision FD Vario 3D, (6) Vision R, (7) Vision RFD, (8) Vision Vario 3D, (9) Vista Plus, (10) 8000. Footswitch Material No. 20125
Reason of Field Safety Corrective Action:Ziehm Imaging has been notified by its supplier that some type KF21 double foot switches may fail to switch off radiation after starting the exposure
Remedy Action:Ziehm Imaging has decided to initiate a voluntary remedial action and will exchange the double foot switch
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh (01) 4041717
Report Source:NCMDR
Source Ref. Number:424321CFA921E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Urgent_Safety_Notice.pdf