Health product recall

Syngo.Via

Last updated

Summary

Product
Syngo.Via
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Syngo.Via

More than 10 numbers, contact manufacturer.

10496180

Issue

Shift of FMRI overlay and no direct possibility to correct the alignment contribute to an incorrect surgery planning when not detected:
- The original error is not generated in the software but a manual error during the scan.
- Incorrect anterior/posterior label can be detected by correlating/comparing with image anatomy.

Recall start date: Apr 26, 2022

Additional information

Details
Original published date: 2022-05-04
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies

Siemens Healthcare Gmbh

Henkestr. 127, Erlangen

Germany, 91052

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64141