Product Wiki · Recalls · Health Canada — Medical Devices

QAngio XA 3D — recall 76759

Health Canada — Medical Devices · Canada · 2024-12-24 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76759
Date of alert
2024-12-24
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: For certain Siemens XA images, the isocenter calibration value is calculated incorrectly due to an incorrect value for distance source to isocenter that is saved by Siemens in the standard dicom attribute (0018,1111). The correct value is stored in a Siemens private dicom attribute (0021, xx17, "Siemens sms-ax acq 1.0") in the dicom data. Incorrect calibration can lead to errors in the measurements provided by qAngio XA 3D. Recall start date: December 16, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/qangio-xa-3d

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