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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:195164

NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

Official recall number

Z-1561-2022

Evidence summary

Product code
OIR
Recall status
Terminated
Event initiated
July 11, 2022
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1561-2022