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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:183278

Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Official recall number

Z-0446-2021

Evidence summary

Product code
JAK
Recall status
Open, Classified
Event initiated
August 05, 2020
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0446-2021

Field note

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