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
NCAR Recall
Reference Number: mdprc 060 06 11 000
Date submitted: 6/18/2011
Manufacturer:Visionsense Ltd
Device Type:Laparoscope Integrated Camera, VS II
Description:Cameras, Video, Endoscopic
Medical Device Identifier:VSII Laparoscope Integrated 0 Deg Camera. 30 Degree cameras are fit for use and are not affected by this recall.
Reason of Field Safety Corrective Action:may have an improperly sealed metal and glass window in the tip of the scope and possibly a mis-assembled camera head positioned behind the window. This combination of factors may lead to the metal and glass window becoming dislodged from the scope tip during cleaning and render the unit inoperable. The metal and glass window may also become dislodged during use therefore may represent a potential health hazard.
Remedy Action:Do not put these units into service. These units are to be returned to Visionsense immediately for inspection and repair if required. Replacement units will be provided for your use.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:UK-2011-06-16-081
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments