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 041 11 12 000
Date submitted: 11/12/2012
Manufacturer:Verathon Inc
Device Type:Verathon~, maker of GlideScope video laryngoscopes
Description:GlideScope Video Laryngoscopes
Medical Device Identifier:manufactured between December 2010 and August 2011, are compatible with the GVL (analog) GlideScope monitor (0570-0200/0231-0003) only. Glide5cope GVL 3 [part # / Serial Numbers}: 0574-0007 / MD10500 to MDl12387 GlideScope GVL 4 [part # / Serial Numbers}: 0574-0001 / LG105000 to LG112758 GlideScope GVL 5 [part # / Serial Numbers}: 0574-0030 / XL105000 to XL111798
Reason of Field Safety Corrective Action:The problem associated with the affected product is the risk of stress cracks developing in the blade tip that may not be readily visible during routine inspection prior to intubation. This cracking may eventually cause the product to fail
Remedy Action:Verathon will replace your affected video laryngoscope blade with new product at no cost to you. Your Verathon sales representative will be contacting you shortly regarding replacement units. Your replacement unit(s) will carry a full one year warranty
Athorized Representative/Importer/Distributor:Techno-Orbits Establishment, Riyadh, (01) 2293 142
Report Source:NCMDR
Source Ref. Number:037A0A7EA91AE
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Verathon Inc.pdf