SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 031 10 17 000
Date submitted:	10/8/2017

Manufacturer:	Elekta Inc
Device Type:	ERGO++ and ERGO Localizer
Description:	Medical electronics / Electromedical devices - electrotherapy
Medical Device Identifier:	Sites affected will be those: 1.Running ERGO® version 1.7.3 and higher and, 2.Using a Multileaf Collimator (MLC) device for planning
Reason of Field Safety Corrective Action:	Elekta has become aware of the potential for incorrect DICOM mapping of the exported collimator or couch angles from ERGO®, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
Remedy Action:	Possible actions include: 1. Halting the distribution and installation of the product indefinitely 2. Updating the device installation instructions to include a test to ensure DICOM export values are mapped correctly.
Athorized Representative/Importer/Distributor:	Medical Regulations Gate
Report Source:	NCMDR
Source Ref. Number:	2EC1B28A3F26A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Elekta Inc..pdf

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