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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 075 12 11 001
Date submitted: 9/3/2012
Manufacturer:Elekta Inc
Device Type:Radiology, X-ray, Digital Accelerator
Description:Radiology, X-ray
Medical Device Identifier:Machine range 105361 to 152584
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MHRA update code:
Machine range 105071 to 105360
Reason of Field Safety Corrective Action:Malfunction of the Modulator Reverse Diode. This can cause ceramic material and silicone oils to eject from the modulator assembly. Also it can cause injury to Service personnel when they do work in Area 30 of the Digital Accelerator.
Remedy Action:Modification kit (FCO 20000103034) is available. The modification kit is installed to prevent injury if the Modulator Reverse Diode fails. Until the Modulator Reverse Diode cover is installed, Elekta recommends that service personnel always wear protective safety glasses when they do work on the modulator assembly with the covers removed. Elekta also recommends that users make sure that the modulator cover is installed when the digital accelerator is in operation. The local Business Unit representative will contact you to organize the installation of the cover.
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MHRA update action:
As a failure of the diode cannot be prevented, this notice tells Users that the modification kit (FCO 200 02 103 050) is available. The modification kit is installed to prevent injury if the Modulator Reverse Diode fails. Until the Modulator Reverse Diode cover is installed, Elekta recommends that service personnel always wear protective safety glasses when they do work on the modulator assembly with the covers removed. Elekta also recommends that users make sure that the modulator cover is installed when the digital accelerator is in operation. The local Business Unit representative will contact you to organize the installation of the cover.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh , (01) 2119999
Report Source:NCMDR
Source Ref. Number:2AF2A2468628A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Elekta.pdf