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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:209977

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Official recall number

Z-3158-2024

Evidence summary

Product code
IZL
Recall status
Open, Classified
Event initiated
November 23, 2023
Root cause
Radiation Control for Health and Safety Act
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-3158-2024

Field note

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