Siemens CT Software Recall for Sporadic 3D Reconstruction Hang-Ups
Siemens Medical Solutions is recalling 896 Somatom CT systems due to sporadic software malfunctions that cause 3D reconstructions to hang during preview.
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 (2) when no hospitalizations or serious injuries are reported, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 896 units of Siemens Somatom CTs equipped with specific software versions (syngo CT2010A, syngo CT2010B, syngo CT2011A, and CT2012B). The recall is due to sporadic hang-up malfunctions that occur concerning 3D reconstructions when the "Preview Image" functionality is activated.
The affected computed tomography x-ray systems were distributed nationwide. The specific model numbers involved are 7740769, 8098027, 10430603, and 10590000. This is a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software malfunction. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.
The recalled product
- Product
- Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 896
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 (4)
- Model numbers - 7740769
- 8098027
- 10430603
- and 10590000.
Distribution
Distributed nationwide across the United States.
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