Public recall detail

QAngio XA 3D

2024-12-24

medium
Recall Safety notice
Quick summary

Quick summary: QAngio XA 3D. Date: 2024-12-24.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: QAngio XA 3D. Date: 2024-12-24.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMedis Medical Imaging Systems B.V.
ProductQAngio XA 3D
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76759

Affected products

ProductQAngio XA 3D
LotNot applicable
Model2.2.2.4
Serial numberNot applicable
DescriptionQAngio XA 3D

Issue

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 you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesMedis Medical Imaging Systems B.V. Schuttersveld 9, Leiden, Netherlands, 2316 XG
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76759
Background{}
CompaniesMedis Medical Imaging Systems B.V. Schuttersveld 9, Leiden, Netherlands, 2316 XG
AudiencesHealthcare
Source updated2024-12-24

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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