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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:113677

Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are 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-0786-2013

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
September 18, 2012
Root cause
Radiation Control for Health and Safety Act
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0786-2013