Health product recall

Syngo.Via (2020-06-22)

Starting date:
June 22, 2020
Posting date:
July 17, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73545

Last updated:
2020-07-17

Affected Products

Syngo.Via

Reason

Siemens has identified the following technical issue if MR images have been acquired with customized scan protocols and loaded into Syngo.Via RT image suite for postprocessing with the option "synthetic CT": if the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in "synthetic CT", the software does not recognize the adapted acquisition plane. This may result in images with incorrect geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded

Affected products

Syngo.Via

Lot or serial number
  • 130218
  • 130453
  • 132308
Model or catalog number

Not applicable.

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY