Siemens Syngo RT Oncologist software update addresses safety issues
Siemens Medical Solutions is updating Syngo RT Oncologist software versions 4.2 and 4.3 to fix safety and performance issues.
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 temporary or medically reversible adverse health consequence. The source describes the action as providing a software update for safety and performance fixes without reporting specific injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 14 units of the Syngo RT Oncologist software, an optional accessory to linear accelerator systems used for radiation therapy planning. The recall involves units currently running software version 4.2 or 4.3.
The recall is intended to provide a software update that contains important safety and performance fixes. These fixes address safety-related issues previously described in a Customer Safety Notice regarding UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration].
The affected units were distributed to facilities in Massachusetts, Missouri, Ohio, Pennsylvania, Utah, and Wisconsin. Siemens is providing the update to resolve the identified safety concerns.
The recalled product
- Product
- Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 14
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)
- Model Number of device- 10568604
Distribution
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