Recall Z-2388-2016— Edan Diagnostics
Class II · Terminated
Class II FDA medical device recall by Edan Diagnostics, initiated 2016-06-23, terminated 2016-11-16. It names 4 FDA 510(k) clearances: K131971, K113653, K113623 and 1 more. 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..
- Recalling firm
- Edan Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-23
- Terminated
- 2016-11-16
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K131971 — IM60/IM70 PATIENT MONITOR
- K113653 — PATIENT MONITOR
- K113623 — PATIENT MONITOR
- K110922 — PATIENT MONITOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.