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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:145696

Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Official recall number

Z-1875-2016

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
April 08, 2016
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1875-2016

Field note

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