Device evidence

device-recall:cfres:213228

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.

Official recall number

Z-1581-2025

Evidence summary

Product code: OWB
Recall status: Open, Classified
Event initiated: February 25, 2025
Root cause: Labeling design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1581-2025