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