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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
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
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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