Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0020-2016·Announced 2015-10-14

Siemens SOMATOM Definition Flash CT Scanner Software Recall

Siemens Medical Solutions USA is recalling 113 SOMATOM Definition Flash CT scanners due to a software bug in version VA48A_SP0 that affects visual warnings and image quality.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes software corrections for visual warnings and image quality without reporting specific injuries or hospitalizations, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 113 units of the SOMATOM Definition Flash, a medical device intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall is due to software bug issues in software version VA48A_SP0.

The software update resolves several safety issues, including corrections to improve visual warning and error indication on the gantry display, improvements to acquisition data to optimize image quality, and enhancements to robustness and general system behavior in exception handling procedures. The affected units were distributed nationwide.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the software update. Consumers are not directly affected as this is a professional medical device.

The recalled product

Product: SOMATOM Definition Flash; 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
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-bug
image-quality
visual-warning
Affected units: 113

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.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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