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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 113 03 12 000
Date submitted: 3/31/2012
Manufacturer:Philips Healthcare
Device Type:Computed Tomography, Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CT
Description:Computed Tomography
Medical Device Identifier:Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CT
Reason of Field Safety Corrective Action:Philips received a complaint that there were loud noises coming from a couch. The couch was sent back to Philips for analysis. Philips determined that metal blocks supporting the scissor slide rails underneath the couch were not manufactured to specifications and may crack.
Remedy Action:If you hear unusual noises when moving the couch vertically or if there is unintended vertical motion of the couch, we recommend that you contact your Philips representative. Otherwise you do not need to take any action and you may continue to use the affected scanner in normal service.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:83D5BAD62430C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Medical Systems.pdf