syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
FDA Recall Z-2688-2020 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2020-06-24
Date Terminated2023-04-05
Product Quantity21 units
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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