Siemens radiation therapy software may lose treatment structure data
Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.
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 an FDA Class II recall affecting medical device software used in radiation therapy planning. No illnesses or injuries have been reported. The potential for data loss in critical treatment planning information represents a risk of harm to patients, fitting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA is recalling syngo.CT VA20A, VA30A, and VA40A software used in multiple SOMATOM radiation therapy systems. These software versions may lose critical treatment structure data when using the contouring or patient marking workflow to edit a structure set after saving and reopening a study.
The issue could result in an incomplete structure set being sent to the treatment planning system (TPS), which manages patient radiation therapy planning. This data loss may compromise the accuracy of treatment information used in radiation therapy planning.
44 systems distributed nationwide are affected. Healthcare facilities using these Siemens products should verify that their treatment planning workflows are not affected by this issue. Siemens has issued a Class II recall; facilities should contact Siemens Medical Solutions USA, Inc. for updated software and guidance on mitigation steps.
The recalled product
- Product
- syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 44
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 (10)
- 128135
- 128142
- 128136
- 128133 11061670 S/N: 130088
- 130094
- 130090
- 130087
- 130091
- 130092
- 130089
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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