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FDAJune 23, 2016device

EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors,...

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

The hazard

Incorrect CO2 readings with some patient monitors.

What to do

FDA enforcement status: Terminated

Brands named

edan diagnosticsedan

Recall history

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

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