Class II — Edan Diagnostics
| Recalling firm | EDAN Diagnostics, Inc. |
|---|---|
| Registered facility | EDAN Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect CO2 readings with some patient monitors. |
| 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, 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, Res… |
| Quantity | 521 |
| Distribution | Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Malaysia, Macedonia, Nepal, New Caledonia, Nicaragua, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Sudan, Senegal, Sri Lanka, Thailand, Turkey, Un… |
| Initiated | 2016-06-23 |
| Classified | 2016-08-11 |
| Terminated | 2016-11-16 |
| Recall number | Z-2388-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Edan Diagnostics (Z-2388-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74632/
Alerts for EDAN Diagnostics, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.