Siemens SOMATOM CT Software Recall for Workflow Interruptions
Siemens Medical Solutions is recalling syngo.CT software version VA48A_SP5.5 for specific SOMATOM CT models due to scanning workflow interruptions and unexpected user notifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (delay in diagnosis and patient rescans) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling syngo.CT software version VA48A_SP5.5 installed in specific SOMATOM computed tomography (CT) models. The affected models include the SOMATOM Definition Edge (Model #10590000), SOMATOM Definition AS (Model #8098027), and SOMATOM Definition Flash (Model #10430603). The recall covers 2,867 units worldwide and 1,464 units in the United States.
The recall is being conducted because the software may result in scanning workflow interruptions and unexpected user notifications. These issues may lead to a delay in diagnosis and/or patient rescans. The agency has classified this as a Class II recall.
Healthcare facilities using these specific CT models with the affected software version should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue. Consumers are not directly affected by this recall, as the product is a medical device used in professional healthcare settings.
The recalled product
- Product
- syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
- Manufacturer
- Siemens Medical Solutions USA, Inc
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)
- syngo.CT software version VA48A_SP5.5
Distribution
Distributed nationwide across the United States.
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