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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:171641

EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).

Official recall number

Z-1193-2019

Evidence summary

Product code
DXN
Recall status
Terminated
Event initiated
March 21, 2019
Root cause
Use error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1193-2019

Field note

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