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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 075 08 12 000
Date submitted: 8/27/2012
Manufacturer:Philips Healthcare
Device Type:Computed Tomography, Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual
Description:Computed Tomography , X-ray
Medical Device Identifier:Philips Brilliance CT 6, 16, MX8000 v (Serial numbers attached)
Reason of Field Safety Corrective Action:A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Remedy Action:Philips Healthcare is notifying all affected customers of this issue via this Field Safety Notice, and a Philips Field Service Engineer will schedule a time to inspect and repair all the affected systems within approximately 6 months.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:30A479812C1FA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf