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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:196501

EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

Official recall number

Z-0152-2023

Evidence summary

Product code
NVY
Recall status
Open, Classified
Event initiated
September 30, 2022
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0152-2023