Edan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings
Edan Diagnostics is recalling 521 EtCO2 modules used in patient monitors because they may provide incorrect CO2 readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect readings from a medical device used for patient monitoring, which poses a risk of harm if relied upon for clinical decisions, even though no specific injuries are reported in the source text.
Plain-English summary
Edan Diagnostics is recalling 521 EtCO2 modules (Part Number 02.01.210699) due to a defect that may cause incorrect CO2 readings. These modules are optional components for various Edan patient monitors, including the iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B, iM60 Vet, and iM70 Vet models. The monitors are intended for measuring expired CO2 as part of multi-parameter monitoring for adults, pediatrics, and neonates.
The affected units were distributed worldwide, including in the United States (Florida, Kentucky, and California) and numerous international countries such as China, India, Germany, and the United Kingdom. The recall is classified as FDA Class II, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.
Healthcare facilities and users should stop using the affected EtCO2 modules and contact Edan Diagnostics for instructions on how to resolve the issue. No specific corrective action or replacement details are provided in the source text, but the recall is intended to prevent reliance on inaccurate CO2 measurements.
The recalled product
- Product
- 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
- Manufacturer
- Edan Diagnostics
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 521
Distribution
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