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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 105 10 18 000
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.
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.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.