Siemens CT Scanner Recall Due to Software Issue in Dual Spiral Mode
Siemens is recalling 53 SOMATOM Confidence CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.
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. The hazard is a software issue causing scan interruptions, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 53 units of the SOMATOM Confidence computed tomography (CT) scanner, Model Number 10590100. These devices are intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The recall affects units distributed nationwide in the United States.
The recall is due to a software issue found in syngo CT VB10A for Siemens Healthineers CT scanners with a single X-ray tube. This issue creates a potential risk of scans being aborted when using the optional Dual Spiral Dual Energy mode.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for addressing the software defect.
The recalled product
- Product
- SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 53
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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