inforMED
MalfunctionOWB

O-Arm O2 Imaging System

Received Jul 30, 2026 · Event occurred Jul 21, 2026

Report 3004785967-2026-00428 · MDR key 50081090

Device

Generic name

Interventional Fluoroscopic X-ray System

Model number

BI70002000

Catalog number

BI70002000

Product problems

  • Use of Device Problem
  • Failure to Advance
  • Application Program Freezes or Fails to Launch

Patient

69 YR · Female

  • No Clinical Signs, Symptoms or Conditions