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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:168659

Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Official recall number

Z-0307-2019

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
June 07, 2017
Root cause
Software design
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0307-2019

Field note

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