Radiation Therapy Software Risk: Data Loss in Treatment Planning
Siemens radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.
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: This is a Class II medical device recall involving radiation therapy planning software where no illnesses or injuries have been reported. The hazard is a potential for data loss—a theoretical but significant risk in a product designed for radiation therapy treatment planning, where data integrity directly affects patient safety.
Plain-English summary
Siemens Medical Solutions USA is recalling the syngo.via RT Image Suite (versions VB30, VB40, VB50, and VB60) radiation therapy treatment planning software. The software has a defect that may cause data loss when editing treatment structures (contouring or patient marking) after saving and reopening a study.
When the defect occurs, the structure set becomes incomplete. This incomplete data is then sent to the treatment planning system, which could affect treatment planning accuracy. The defect affects 126 units that were distributed nationwide in the United States.
The recalled product
- Product
- syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 126
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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