OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 135 06 12 000
Date submitted: 6/25/2012
Manufacturer:Varian Medical Systems
Device Type: Rectal retractor, titanium, white acetal, ontained in Ring and Tandem Combination Applicator Sets
Description:Brachytherapy Applicators, Tandem/Ovoid, Retractors, Rectal
Medical Device Identifier:Retractor Part No. AL07368000; Applicator Set Part No. AL13017000; All lot numbers
Reason of Field Safety Corrective Action:The Rectal retractors have shown evidence that contaminates, or fluids, have entered into the center of the rectal retractor paddle through the cross pins or bottom rod areas. Using a part in this condition could result in infection, toxicity, or allergic reaction
Remedy Action:Discontinue the use and quarantine the AL07368000 Rectal retractor, titanium, white acetal device. There is no immediate technical correction for this issue. As specified in the Instructions for Use of the AL13017000 Ring & Tandem Combination Applicator Set. Customers that return the AL07368000 Rectal retractor, titanium, white acetal to Varian will be informed when a replacement product becomes available in the future. At that time those customers will be shipped a replacement free of charge.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:4FAF02BB86241
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments