Quick summary
Quick summary: Syngo.Via.
Public recall detail
Syngo.Via
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Syngo.Via.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandSiemens Healthcare Gmbh
ProductSyngo.Via
IssueMedical devices - Software defect
Recall classType II
IdentificationRA-64141
Affected products
ProductSyngo.Via
LotMore than 10 numbers, contact manufacturer.
Model10496180
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSyngo.Via
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Radiology
CompaniesSiemens Healthcare Gmbh Henkestr. 127, Erlangen Germany, 91052
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64141
Background{}
CompaniesSiemens Healthcare Gmbh Henkestr. 127, Erlangen Germany, 91052
AudiencesGeneral public Health professionals Hospitals
Source updated2022-05-03
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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