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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
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ational
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enter for
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edical
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evices
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eporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall
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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
View History
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