Derived label

Device software or design

(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software version VC10, which may result in
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Siemens Medical Solutions USA, Inc