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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:214804

Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

Official recall number

Z-2097-2025

Evidence summary

Product code
KPS
Recall status
Open, Classified
Event initiated
June 20, 2025
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2097-2025

Field note

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