Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1244-2019·Announced 2019-05-08

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.

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. 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
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-defect
scan-interruption
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.

See all 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · software defect