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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:184723

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

Official recall number

Z-0935-2021

Evidence summary

Product code
LWS
Recall status
Open, Classified
Event initiated
December 02, 2020
Root cause
Process change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0935-2021

Field note

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