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
NCMDR Recall
Reference Number: mdprc 105 10 18 000
Date submitted: 10/21/2018
Manufacturer:VOLCANO CORPORATION
Device Type:IVUS Catheter
Description:Catheter
Medical Device Identifier:Catalog number: 88901, 81234
- Please check attachment for batch numbers -
Reason of Field Safety Corrective Action:Philips has received complaints that approximately 20% of devices in affected lots may demonstrate an inability to insert the guidewire into the catheter. This has caused no known adverse events. This issue is seen before entering the patient's body, and can lead to a delay of case while the defective product is exchanged for another device.
Remedy Action:If you experience an issue using a Visions PV .035 device, please report it to the Philips Sales Contact or to the Philips Complaints department by email VEcomplaints@philips.com . Philips will provide a replacement unit for any devices experiencing this issue.
Athorized Representative/Importer/Distributor:Ikar Establishment
Report Source:NCMDR
Source Ref. Number:F9438424C12A5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: VOLCANO CORPORATION.pdf