Siemens SOMATOM Definition Edge CT Scanner Software Recall
Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.
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 classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The issues are software-related (visual warnings, image quality, system robustness) without explicit reports of harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 113 units of the SOMATOM Definition Edge CT scanner. The recall is due to software bug issues in version VA48A_SP0. The affected scanners are distributed nationwide.
The software update resolves several safety issues, including improving visual warning and error indications on the gantry display, optimizing image quality by improving acquisition data, and enhancing system robustness in exception handling procedures. The recall also addresses improvements to auto post-processing.
The affected units are identified by Model # 10590000 with specific serial numbers: 83277, 83281, 83021, 83004, 83014, 83276, and 83279. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for details on the software update.
The recalled product
- Product
- SOMATOM Definition Edge; 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
- Category
- Medical Device — CT Scanner
- Affected units
- 113
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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