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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:188786

SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

Official recall number

Z-2415-2021

Evidence summary

Product code
LNH
Recall status
Completed
Event initiated
August 11, 2021
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2415-2021

Field note

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