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.
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, 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
- 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.
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · image artifacts
See all →- HighMedtronic O-arm O2 imaging systems may produce image artifacts
FDA (Devices) · 2026-06-24
- HighUnited Imaging uCT 550 CT System Recalled for Image Artifacts
FDA (Devices) · 2020-07-29
- ModeratePhilips Brilliance 64 CT Systems Recalled for Image Artifacts
FDA (Devices) · 2019-04-24
- ModerateGE Healthcare Recalls Brivo XR385 Digital Radiographic Systems
FDA (Devices) · 2018-08-01
- HighSiemens CT System Recalled for Image Artifacts and Safety Issues
FDA (Devices) · 2015-03-18