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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 033 07 15 000
Date submitted: 7/7/2015
Manufacturer:Maquet Cardiopulmonary AG
Device Type:Heater-Cooler Unit HCU 40 High Voltage
Description:Heater-Cooler Unit
Medical Device Identifier:All HCU 40s (article number 70104.4054) with the following serial numbers:

90440265, 90440266, 90440269, 90440273, 90440274, 90440275, 90440276, 90440277, 90440278, 90440280, 90440281, 90440283, 90440284, 90440288, 90440289, 90440292, 90440299, 90440300, 90440301, 90440302, 90440303, 90440304, 90440306, 90440307, 90440308, 90440309, 90440310, 90440311, 90440312, 90440313, 90440316, 90440317, 90440318, 90440319, 90440322, 90440324, 90440325, 90440331, 90440337, 90440338
Reason of Field Safety Corrective Action:The HCU 40s with the serial numbers listed above potentially exhibit a leak in the water circuit. In case of water leakage a short circuit of an electrical component and device shut down are the potential consequences.
Remedy Action:-In order to verify that the water circuit of your HCU 40 is tight, your local MAQUET office will contact you.

-As described in the Instruction for Use, always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure

-This notice needs to be passed to all those who need to be aware in your orgabnisation.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System
Report Source:NCMDR
Source Ref. Number:D3164282CD27A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Maquet.pdf