FDA Device recall Z-2388-2016
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Vete…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Vete… by Edan Diagnostics, citing incorrect CO2 readings with some patient monitors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2388-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-23 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Edan Diagnostics |
| Distribution | US |
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
Incorrect CO2 readings with some patient monitors.
Identifiers
| code_info | Part Number Model Serial Number Country 83.60.000703 iM80 000703-M16401550001 Poland 83.60.001840 iM8B 001840-M164015…Part Number Model Serial Number Country 83.60.000703 iM80 000703-M16401550001 Poland 83.60.001840 iM8B 001840-M16401570001 India 83.60.001840 iM8B 001840-M16401570002 India 83.60.001840 iM8B 001840-M16401570003 India 83.60.001840 iM8B 001840-M16401570004 India 83.60.001840 iM8B 001840-M16401570005 India 83.60.001840 iM8B 001840-M16401570006 India 83.60.001840 iM8B 001840-M16401570007 India 83.60.001840 iM8B 001840-M16401570008 India 83.60.002371 IM70 002371-M16306180001 China 83.60.260047 iM70 260047-M16201960001 South Africa 83.60.260047 iM70 260047-M16309400001 Pakistan 83.60.260047 iM70 260047-M16309400002 Pakistan 83.60.260047 iM70 260047-M16309400003 Sudan 83.60.260047 iM70 260047-M16309400004 Pakistan 83.60.260047 iM70 260047-M16309400005 Pakistan 83.60.260047 iM70 260047-M16500950001 Argentina 83.60.260047 iM70 260047-M16500980001 Saudi Arabia 83.60.260047 iM70 260047-M16500980002 Saudi Arabia 83.60.260047 iM70 260047-M16500980003 Saudi Arabia 83.60.260047 i |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2388-2016%22
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