Siemens SOMATOM CT Software Recall for Workflow Interruptions
Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.
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 3/5 (High).
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 involves a medical device where software errors may lead to delayed diagnosis or patient rescan, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a installed in specific Siemens SOMATOM computed tomography (CT) systems. The affected models include SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, and X.cite.
The recall is due to sporadic software errors that may cause scanning workflow interruptions and unexpected user notifications. These issues may result in a delay in diagnosis or require a patient to be rescanned. Sporadic software errors may also occur during interventional workflows.
Approximately 190 units were distributed nationwide in the United States. The source text does not specify instructions for consumers or healthcare providers regarding corrective actions.
The recalled product
- Product
- Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 190
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)
- Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a
Distribution
Distributed nationwide across the United States.
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