Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80 Recalled by Edan Diagnostics Due to Incorrect CO2 readings with some patient monitors.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edan Diagnostics directly.
Affected Products
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, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
Quantity: 521
Why Was This Recalled?
Incorrect CO2 readings with some patient monitors.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edan Diagnostics
Edan Diagnostics has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report