Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2680-2014·Announced 2014-10-01

Siemens Ysio Systems Recalled for Potential Image Artifacts

Siemens is recalling 62 Ysio Systems due to a software error that may cause line artifacts in images, potentially requiring examinations to be repeated.

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 hazard is described as an 'unlikely error' resulting in image artifacts that may require a repeat examination, without reports of injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 62 Ysio Systems with software version VC10. These systems are used for radiographic and tomographic exposures of the whole body, including the skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. The affected units are identified by model numbers 10281013 and 10281163 and were distributed nationwide.

The recall was initiated because Siemens discovered that an unlikely error may occur on the Ysio system with a fixed detector in the wall stand. This error may result in line artifacts appearing in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.

No specific instructions for consumers are provided in the source text, as this is a medical device recall likely managed through healthcare facilities. The agency classification for this recall is Class II.

The recalled product

Product: The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiology Equipment
Hazard: image-artifacts
software-error
Affected units: 62

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Model numbers: 10281013
10281163.

Distribution

Distributed nationwide across the United States.

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 · image artifacts