Azurion 7 M12 and Azurion 7 M20 (2018-03-19)

Starting date:

March 19, 2018

Posting date:

May 1, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66604

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  Reason
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  Affected products

Affected Product

A. AZURION 7 M12

B. AZURION 7 M20

Reason

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, Philips has become aware that 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). If the measurement is re-performed at the external DICOM destination, the result will also be incorrect unless a recalibration of the image is executed.  Note: The QA Basic Measurement tool is used to perform distance measurements, so that the user has an indication on the size of anatomical structures or devices.  Measurements performed using the Quantitative Vascular Analysis, the Quantitative Coronary Analysis, the Left Ventricular Analysis or the Right Ventricular Analysis packages are NOT affected by this issue.

Affected products