Siemens Syngo RT Software Recalled for Sporadic System Crashes
Siemens is recalling Syngo RT Therapist and Oncologist software versions 4.3.SP1 due to sporadic system crashes that prevent unloading patient data.
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 corresponds to a moderate severity score. The source text describes a software defect causing system crashes and data unloading issues, but does not report any injuries, illnesses, or deaths, nor does it describe a direct physical hazard like radiation exposure or structural failure.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Syngo RT Therapist and Syngo RT Oncologist software applications, version 4.3.SP1. These software applications are used with Siemens brand linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The recall is being conducted because Siemens became aware of a potential issue where the software may experience sporadic system crashes. These crashes can cause an inability to unload patient data from the system.
The recall affects 56 units distributed in Utah, Wisconsin, and New York. Affected units include Syngo RT Therapist (RTT 4.3.SP1) model no. 08162815 and Syngo RT Oncologist (RTO 4.3.SP1) model no. 10568604. Specific affected unit numbers for Syngo RT Therapist in the U.S. are 10010, 10046, and 10586. No Syngo RT Oncologist units are listed for the U.S. in the source text.
The recalled product
- Product
- Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 56
Distribution
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