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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 003 11 15 000
Date submitted: 11/1/2015
Manufacturer:Getinge Disinfection AB
Device Type:ED FLOW and POKA YOKE
Description:Washer Disinfectors
Medical Device Identifier:All
Reason of Field Safety Corrective Action:Quality improvements have been implemented on our washer disinfectors in production to make them more durable to the cleaning and disinfection chemistry. It was decided to perform an update of washers already installed at customer sites so that that our existing customers can also benefit from the improvements.
Remedy Action:-Identifying the device, and the necessary update level

-Modification of device by one of our technician
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:C7C696FE883A9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Getinge Disinfection.pdf