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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:129444

Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Official recall number

Z-0409-2016

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
March 03, 2011
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0409-2016

Field note

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