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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 069 10 15 000
Date submitted: 10/20/2015
Manufacturer:Advanced Sterilization Products
Device Type:STERRAD NX Sterilization System
Description:Sterilization System
Medical Device Identifier:P/N 10033 (STERRAD® NX® Sterilization System)
Reason of Field Safety Corrective Action:ASP has recently identified that a STERRAD® NX® Sterilization System may exceed the radiated emissions International Standard limit by 20 decibel micro-volt per meter (dBμV/m), which equates to 0.001 volt per meter (V/m) at a distance of 10 meters.
Remedy Action:ASP advises you to continue to take the precautions normally exercised for adjacency of STERRAD® NX® Sterilization System with other electromechanical equipment and electronic medical devices.

ASP has not received any complaint or adverse event reports associated with the above non-conformance.

ASP will begin the process of correcting systems to reduce the emissions to meet the International Standard limit within the next 90 days. ASP will contact you to schedule a service once the correction is in place.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:5FFB4B08D6283
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Advanced Sterilization Products.pdf