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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:108856

Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.

Official recall number

Z-1849-2012

Evidence summary

Product code
IZL
Recall status
Terminated
Event initiated
October 12, 2010
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1849-2012

Field note

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