The Recall Desk
HighFDA (Devices)·Z-2445-2021·Announced 2021-09-22

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.

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: 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
Category
Medical Device — Radiation Therapy Software
Hazard
  • data-loss
  • incomplete-data

Distribution

Distributed nationwide across the United States.

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