Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1246-2019·Announced 2019-05-08

Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode

Siemens is recalling 53 SOMATOM Edge Plus 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional software defect (scan abortion) rather than a direct physical injury risk, 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 Edge Plus computed tomography (CT) scanner, Model Number 10267000. These devices are intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The recall is due to a software issue found in syngo CT VB10A that may cause scans to be aborted when the optional Dual Spiral Dual Energy mode is used on single X-ray tube scanners. The affected units were distributed nationwide in the United States.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue. Consumers should not use the affected Dual Spiral Dual Energy mode until the issue is resolved.

The recalled product

Product: SOMATOM Edge Plus, Model Number 10267000 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-abortion
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

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