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Official recall record

QAngio XA 3D

Health Canada — Medical Devices · 2024-12-24 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-12-24
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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