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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 133 12 13 000
Date submitted:
12/17/2013
Manufacturer:
MAQUET Inc
Device Type:
Compressor Mini with insufficient cooling
Description:
Compressor
Medical Device Identifier:
Please see attached
Reason of Field Safety Corrective Action:
Listed compressor units manufactured from February 2012 to June 2013 have been found to potentially have an insufficient crimping of a blade connector receptacle between the thermoelectric cooler and a thermostat.
Remedy Action:
MCC has initiated an immediate update of Compressor Mini units potentially affected by the issue outlined above (see attached list for affected serial numbers). Customers with affected Compressor Mini units will be contacted by their local MAQUET representative for update of those units .
Athorized Representative/Importer/Distributor:
Gulf Medical Co., (012)6512828
Report Source:
NCMDR
Source Ref. Number:
352990474C181
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
MAQUET Inc.pdf
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.