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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 020 04 12 000
Date submitted: 4/7/2012
Manufacturer:Philips Medical Systems
Device Type:Radiographic system, DigitalDiagnost
Description:Radiographic system, x-ray images
Medical Device Identifier:DigitalDiagnost with software version 2.x and the image stitching option
Reason of Field Safety Corrective Action:Potential misdiagnosis due to improper Philips image ruler handling or to improperly automatically stitched images
Remedy Action:Ruler handling for measurements: When a lead ruler is used for clinical measurements, then please carefully follow the Instruction for Use chapter “Measurements” of the Eleva Workspot manual. Do not use the Philips image ruler for measurements. Automatic stitching: Automatic stitching is not always successful. Always check the composite stitched image results against the single images carefully prior to using it for any clinical purpose. Incorrectly stitched images must be manually corrected. For stitching procedures, only use the Philips image ruler. Do not use the Philips image ruler for other examinations than stitching examinations.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:035A4ADF721F8
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Medical Systems.pdf