Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update
Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.
What this means for you
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 for a software update to fix bugs and improve performance without reported injuries, illnesses, or specific safety hazards, fitting the criteria for a voluntary precautionary recall or minor issue.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 104 SOMATOM Definition Flash System units. These are computed tomography (CT) scanners intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The systems were distributed nationwide.
The recall is being conducted to provide a software and firmware update. This update includes bug-fixes designed to improve system performance. The source text does not specify the nature of the bugs or any specific safety hazards associated with the current software version.
Affected units are identified by specific serial numbers listed in the recall documentation. Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. to arrange for the installation of the necessary software and firmware updates.
The recalled product
- Product
- SOMATOM Definition Flash System, x-ray, tomography, computed Intended 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 angles or spiral planes taken at different angles
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 104
Distribution
Distributed nationwide across the United States.
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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