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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 086 08 17 000
Date submitted: 8/24/2017
Manufacturer:Philips Healthcare Gamma Cameras
Device Type:Allura Xper R9 and Azurion R1.1
Description:imaging systems
Medical Device Identifier:Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool. Product names: Allura Xper R9 7M12, Allura Xper R9 7M20, Azurion 7M12; Azurion 7M20; Azurion 3M12; Azurion 3M15
Reason of Field Safety Corrective Action:In order to save archiving space, the Allura Xper R9 systems and Azurion R1.1 systems include the option of downscaling the image when exporting images to the external DICOM destination (e.g., PACS).
When using the downscale option, the measurements performed with the Allura R9 system or Azurion R1.1 system using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination.
The difference between the original measurement and the exported measurement can vary. The distance value after export is factor 1 to 4 smaller than the original value. The difference will depend on the acquired image (e.g., X-ray protocol, field of view) and the used archive settings (i.e., downscale settings).
Remedy Action:The problem will be resolved by a software update, which is expected to be available by the end of 2017. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:83CB0BE1B02EA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare .pdf