Recall Z-2688-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
| Date | Jun 24, 2020 |
| Status | Terminated |
| Reason | 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 wrong 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. The occurence of this issue is very unlikely and has never been reported so far. |
| Root cause | Software design |
| Action | Siemens Healthcare Diagnostics sent a letter notification to customers dated June 23, 2020. The described issue will be solved with a service pack for software versions syngo.via VB30 and syngo.via VB40. Depending on your current software version, the service pack VB30A_HF08 will be installed with update SY039/20/S or the service pack VB40B_HF01 with update SY040/20/S as soon as it is available. |
| Quantity | 21 units |
| Distribution | US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192065 | Syngo.Via RT Image Suite Siemens Medical Solutions USA, Inc., Sep 18, 2019 |