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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:147895

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

Official recall number

Z-2114-2016

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
June 21, 2016
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2114-2016

Field note

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