Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 138 05 16 001
ACCELERATOR Automated Processing System (APS)
Medical Device Identifier:
List Number : 07L02
NCMDR update code :
ACCELERATOR a3600 Centrifuge Module
List Number : 06P37
Reason of Field Safety Corrective Action:
Abbott Diagnostics has been notified that the manufacturer of the centrifuge recommends an immediate reduction in the operating speed of the centrifuge not to exceed a maximum of 3500 RPMs. Material changes may have had an impact on the bucket strength, which could lead to the bucket becoming dislodged in the centrifuge
-Immediately reduce the maximum RPMs to 3500.
-Visually inspect your centrifuge buckets for cracks If any cracks are identified OR if the “useable until” date has expired, immediately stop using the centrifuge.
-Contact Customer Service to arrange for replacement buckets.
-Continue to perform Weekly Maintenance per the ACCELERATOR APS Operations Manual (580799015.0, September 2014).
Medical supplies & Services Co.Ltd Mediserv
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.