Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes
Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve 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 classified as FDA Class II and involves a software update to fix bugs and improve performance. No injuries, illnesses, or deaths are reported, and the hazard is theoretical, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 104 SOMATOM Definition AS Systems, which are computed tomography (CT) scanners used to produce cross-sectional images of the body. The recall involves a software update that provides software and firmware bug-fixes to improve system performance.
The affected systems were distributed nationwide. The recall is limited to specific serial numbers listed in the agency's documentation. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities 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 AS 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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