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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:172629

NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Official recall number

Z-1280-2019

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
October 22, 2018
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1280-2019

Field note

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