The Recall Desk
HighFDA (Devices)·Z-0994-2022·Announced 2022-05-04

Radiation therapy software update displays incorrect laser positioning

Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of medical device software used in radiation therapy. Although no illnesses or injuries have been reported, incorrect laser offset coordinates represents a theoretical risk of harm in radiation therapy patient positioning and treatment planning.

Plain-English summary

Siemens Medical Solutions is recalling the syngo.via RT Image Suite when upgraded to software version VB60, running on syngo.via servers (Model Number 10496180) and compatible CT scanners with syngo.CT VA40A software. The recall involves a software upgrade that automatically modifies laser configuration settings in the imaging workflow.

The automatic laser configuration change may result in incorrect laser offset coordinates being displayed in the Patient Marking step of radiation therapy. Accurate laser positioning is critical for proper patient alignment and treatment planning in radiation therapy.

The affected devices have been distributed nationwide across the United States and internationally to multiple countries including Argentina, Austria, Brazil, France, Germany, India, Italy, Japan, and the United Kingdom.

Siemens Medical Solutions USA, Inc. recommends that healthcare facilities using the affected software review their laser configuration settings and verify alignment accuracy. Facilities should contact Siemens for guidance on addressing this issue.

The recalled product

Product
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Radiation Therapy Imaging Software
Hazard
  • incorrect-laser-offset
  • positioning-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number 133527

Distribution

Distributed nationwide across the United States.

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