Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes
Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.
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 for a software update to fix bugs and improve performance, with no reported injuries or illnesses, fitting the criteria for a voluntary precautionary recall or minor issue.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 104 units of the SOMATOM Definition Edge System, a computed tomography (CT) scanner used to produce cross-sectional images of the body. The recall is being conducted to install a software update that provides software and firmware bug-fixes to improve system performance.
The affected systems were distributed nationwide. The recall covers specific serial numbers associated with Model # 10590000. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers with these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for instructions on installing the software update.
The recalled product
- Product
- SOMATOM Definition Edge 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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