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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 068 12 17 000
Date submitted: 12/21/2017
Manufacturer:Philips Healthcare
Device Type:All Allura Xper, AlluraClarity, Allura CV, Allura Centron, UNIQ and Integris systems
Description:Radiographic/Fluoroscopic Systems, Angiography/Interventional
Medical Device Identifier:Multiple affected product are provided in the attached FSN
Reason of Field Safety Corrective Action:This Field Safety Notice is intended to inform you that users have reported two instances of patient injury or death in which operators misinterpreted still images displayed by Philips x-ray systems as live images.
In each of these cases multiple system indicators and safeguards intended to inform users about the type of image they are viewing were working properly.
Remedy Action:- Philips is distributing this safety notice to all known customers, and asking them to ensure that users review again the applicable provisions for their systems.
- Philips is advising the customer to follow the applicable instructions for use (IFU) belonging to the system.
- For your convenience Philips will provide separately a Quick Reference Guide “Live Imaging”, which provides a summary of all relevant indications of live imaging.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:09430806449E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf