FDAJune 5, 2019device

PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The monitor displays an error message . The error message states "internal error restart or service".

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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