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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:180583

Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.

Official recall number

Z-1810-2020

Evidence summary

Product code
DPS
Recall status
Terminated
Event initiated
March 18, 2020
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1810-2020

Field note

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