Device product

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

Z-0374-2014

September 03, 2013

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 66231
Status: Terminated
Classification: Class II
Quantity: 357
Official record key: device-enforcement:Z-0374-2014

Official wording

Reason: A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.

Code information: Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada.

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

software version VC10, which may result in