SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 050 04 16 000
Date submitted:	4/12/2016

Manufacturer:	Philips Healthcare
Device Type:	Juno DRF .
Description:	X-ray system
Medical Device Identifier:	All
Reason of Field Safety Corrective Action:	We became aware that an operator got hurt while relocating a patient from Juno DRF table onto the patient’s bed. Standing behind the table top between the left table top support arm and the detector holder, he got squeezed between the left table top support arm and the detector holder.
Remedy Action:	Philips will provide improved directions for use (including device labeling) that include: - An additional warning sign ISO 7010:2011 W019 - A prohibition sign banning access to the prohibited area. -Additional Safety information to be attached the the IfU precisely explaining o the prohibited area o the hazard o countermeasures in case of a violation of the prohibition o the additional device labeling.. You will be contacted by Philips to schedule the installation. Should you need to communicate with Philips with regard to this program, please reference FCO-70900032.
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd.
Report Source:	NCMDR
Source Ref. Number:	DA0FD6F49D350
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips Healthcare.pdf

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