Siemens Medical Imaging Systems Recalled for Potential Radiation Overexposure
Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (radiation overexposure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 192 Luminos dRF, Ysio, or Uroskop Omnia diagnostic imaging systems. The affected units are equipped with software versions VB10C through VB10F and utilize automatic exposure control.
The recall was initiated because a highly unlikely malfunction in these systems can result in radiation exposure that is longer than required during a RAD examination. This malfunction may also produce overexposed images that lack diagnostic quality, necessitating that the examination be repeated.
The affected products were distributed nationwide. Consumers and healthcare providers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 192
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 (4)
- model numbers 10094200
- 10281163
- 10281013
- 10094910 with multiple serial numbers
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 · radiation overexposure
See all →- HighX-Ray imaging systems may allow radiation exposure beyond safety limits
FDA (Devices) · 2025-02-12