X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 126 12 14 000
Date submitted: 12/23/2014
Manufacturer:Intuitive Surgical Inc
Device Type:da Vinci Si Surgical System, IS3000
Description:Robotic surgical system
Medical Device Identifier:All IS3000 Vision
Side Carts, model VS3000 (PN 371683-05)
Reason of Field Safety Corrective Action:Intuitive Surgical has taken the decision to initiate a voluntary correction relating to the da Vinci Si System (IS3000) Vision Side Carts, with caster wheels that have a threaded-in design. The correction is being implemented to address the potential for the Patient Side Cart wheels to loosen and potentially dislodge from the cart.
Remedy Action:The da Vinci Si Vision Side Cart can continue to be used safely. The Preventive Maintenance (PM) frequency for the VSC caster wheel assemblies will be increased from every six months, during system PM, to every three months.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCAR
Source Ref. Number:CH-2014-12-19-125
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20141217_09-e1.pdf