Device evidence

device-recall:cfres:214001

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

Official recall number

Z-1819-2025

Evidence summary

Product code: OXO
Recall status: Open, Classified
Event initiated: March 21, 2025
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1819-2025