Siemens SOMATOM Emotion 6 CT Scanner Software Recall
Siemens Medical Solutions is recalling 75 SOMATOM Emotion 6 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
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 describes software bugs causing operational issues and potential rescans without reporting any injuries, hospitalizations, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary measures where no harm is reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 75 units of the SOMATOM Emotion 6 computed tomography (CT) scanner. The recall is due to software bugs in VC20B SP0a or SP1 software versions that may cause issues requiring patients to be rescanned. The affected units were distributed nationwide, including Puerto Rico.
The software defects may cause the Syngo Main UI to crash if the Patient Browser is scrolled with keyboard arrow keys. Additionally, Tomo images may freeze on the screen when zoomed in or out under the CAREVision mode. Users may also experience sporadic displaying errors in the WorkStream4D application, and the database may lock under heavy multitasking conditions.
Healthcare facilities using these specific serial numbers (29338, 27232, 27230, 27231) should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software issues.
The recalled product
- Product
- SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 75
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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