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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:208064

EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Official recall number

Z-2198-2024

Evidence summary

Product code
LWS
Recall status
Open, Classified
Event initiated
April 16, 2024
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2198-2024

Field note

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