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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 048 07 15 000
Medical Device Identifier:
Affected Products : REM-DF02, REM-DF04, REM-DF06, REM-DF07 - ALL BATCHES
Reason of Field Safety Corrective Action:
Zethon has identified that there is no documented evidence that they meet the basic safety and performance requirements of the medical device regulations. This effectively invalidates the CE-mark (found on the label and insert), and Zethon is recalling the product with immediate effect.
Return affected products to the manufacturer.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.