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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 048 07 15 000
Date submitted: 7/23/2015
Manufacturer:Zethon Ltd
Device Type:Fibrillation cables
Description:Fibrillation cables
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.
Remedy Action:Return affected products to the manufacturer.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:UK-2015-07-17-146
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zethon (ZFSN-001).pdf