Siemens SOMATOM CT Scanner Software Recall for Scan Parameter Issues
Siemens is recalling specific SOMATOM CT scanner systems due to a software issue that may prevent scan cancellation and reloading, potentially delaying diagnosis or requiring patient rescans.
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, but the source text explicitly states no injuries or illnesses have been reported, only potential delays in diagnosis or need for rescans, which aligns with the Moderate severity criteria for low-risk issues without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 3,044 units of SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence, and Edge Plus CT scanner systems. The recall involves systems equipped with syngo.CT VB20A_SP2 software. The affected units were distributed nationwide in the United States.
The recall is due to a software defect where the system does not trigger a cancel command followed by a reload of the scan with new parameters. This issue may result in a delay in diagnosis and/or the need for a patient rescan.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this software issue. Patients who have had scans on these systems should consult their healthcare provider if they have concerns regarding their diagnostic results.
The recalled product
- Product
- SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 3,044
Distribution
Distributed nationwide across the United States.
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