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Qangio xa 3d

Official notice

24 Dec 2024

Last checked

24 Dec 2024

Critical riskHealth Canada

An official Health Canada notice concerns Qangio xa 3d. 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 Published 2024-12-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76759

Official notice

2024-12-24

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76759

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Affected products

Product 1

Affected products - QAngio XA 3D, Lot or serial number - Not applicable, Model or catalogue number - 2.2.2.4

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medis Medical Imaging B.v, Qangio Xa 3d.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

76759

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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