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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:180460

RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Official recall number

Z-2293-2020

Evidence summary

Product code
PGY
Recall status
Open, Classified
Event initiated
July 30, 2019
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2293-2020

Field note

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