Derived label

Device software or design

Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Software issue
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: LIEBEL-FLARSHEIM COMPANY LLC