Radiographic system software error may cause unintended tube stand movement
Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
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: This is a Class II medical device recall for a risk-of-harm product (unintended equipment movement with collision potential) where no actual illnesses or injuries have been reported in the source text. Per the severity rubric, such recalls without reported harm are classified as High (3).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 70 Ysio fully automated radiographic systems (Model Number 10281013 with VC10 software version) that were distributed nationwide in the United States.
The recall is due to a software error in previous software version VB10. This error causes the system to process incorrect internal values for the position of the ceiling tube stand. When a user activates a longitudinal or transversal movement, the system controls may initiate an unintended correction movement of the tube stand.
This unintended movement creates a potential collision risk for objects or persons in the vicinity of the moving stand. The manufacturer indicates this may result in minor to serious injuries to persons.
Facilities operating affected systems should verify their unit serial numbers against the recall notice and contact Siemens Medical Solutions USA, Inc. for guidance on corrective measures.
The recalled product
- Product
- Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- unintended-movement
- collision-risk
- software-error
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03