EtCO2 Module -Part Number: 02 — Class II medical device recall Z-2388-2016
Terminated recall by Edan Diagnostics, reported 2016-08-17, distributed nationwide. Incorrect CO2 readings with some patient monitors.
| Recall number | Z-2388-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edan Diagnostics, San Diego, CA, United States |
| Recall initiated | 2016-06-23 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CN, CO, DE, FR, GB, GT, IN, IT, LK, LT, MY, NI, NP, PK, PL, PT, RU, SA, TH, TR, UY, ZA |
| Quantity | 521 |
| Model numbers | 02.01.210699 |
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, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
Reason for recall
Incorrect CO2 readings with some patient monitors.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.