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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:211984

ARTIS One Angiographic X-Ray System

Official recall number

Z-0922-2025

Evidence summary

Product code
OWB
Recall status
Open, Classified
Event initiated
January 02, 2025
Root cause
Radiation Control for Health and Safety Act
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0922-2025

Field note

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