QAngio XA 3D
Brand(s)
Last updated
Summary
Product
QAngio XA 3D
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| QAngio XA 3D | Not applicable | 2.2.2.4 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
| Medis Medical Imaging Systems B.V. |
| Schuttersveld 9, Leiden, Netherlands, 2316 XG |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76759
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