Siemens syngo RT Dosimetrist 2.7 software update addresses data storage issue
Siemens Medical Solutions is updating syngo RT Dosimetrist 2.7 software to fix a safety issue where structure names were not stored correctly.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The issue is a software data storage error rather than a direct physical hazard.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling seven units of the syngo RT Dosimetrist 2.7 system to address a safety issue in the Virtual Simulation software. The recall involves an update to the software to correct a defect in the Structure Operations function.
In special scenarios, the system failed to store the selected name from a list of predefined names. After reloading the data, the system changed the structure name. The update also addresses a performance issue related to the import of DICOM data.
The affected units were distributed in New Hampshire, Tennessee, Ohio, Virginia, and Texas. The specific serial numbers are 10201, 10231, 10237, 10266, 10267, 10305, and 10272. Users should contact Siemens Medical Solutions for the software update.
The recalled product
- Product
- Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 7
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 (2)
- material number: 10568604
- with serial numbers 10201 10231 10237 10266 10267 10305 10272
Distribution
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