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Terminated

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).

FDA Recall Z-2388-2016 · Posted None

Recalling FirmEdan Diagnostics
Recall StatusTerminated
Product CodeMHX
Date Initiated2016-06-23
Date Terminated2016-11-16
Product Quantity521

Reason for Recall

Incorrect CO2 readings with some patient monitors.

Firm Action

The firm, EDAN, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated 6/23/2016 via email to its customers on 06/23/16. The letter described the product, problem and actions to be taken. Customers were provided two possible solutions. 1. Re-calibrate the affected monitors: a. The customer needs to source the Calibration Gas and other tools locally, EDAN will provide the Specifications of the Calibration Gas; b. EDAN will provide Calibration Instructions to the customer; c. The customer need to calibrate the monitors by themselves and send the Calibration Record back to EDAN. 2. Replace the EtCO2 modules on the affected monitors: a. EDAN will provide new, correctly calibrated, EtCO2 modules with replacement instructions free of charge; b. The customer shall replace the modules by themselves and send the Replacement Record back to EDAN; c. The customer shall send the faulty EtCO2 modules back to EDAN. For customers who received affected EtCO2 modules as spare parts: 1. The customer can return the affected modules back to EDAN and ask for a refund or credit, or have these modules replaced with new ones. 2. If any of the affected module has been used on a monitor, the customer should replace the module used with new one. 3. The customer shall send the affected EtCO2 modules back to EDAN. Any questions contact EDAN service engineer who responsible for your country/region or at phone numbers listed below: EDAN Instruments, Inc. Monday to Friday 09:00-17:00 (UTC +08:00) Tel: +86-755-26812296 EDAN Instruments GmbH Monday to Friday 09:00-17:00 (UTC +01:00) Tel: +49 (0) 6103 202 0781 EDAN Diagnostics, Inc. Monday to Friday 09:00-17:00 (UTC -08:00) Tel: +1 858 750 3066

Root Cause

Nonconforming Material/Component

Distribution Pattern

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, United Kingdom, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113653PATIENT MONITOREdan Instruments, Inc. · 2012-02-06K113623PATIENT MONITOREdan Instruments, Inc. · 2012-02-01K110922PATIENT MONITOREdan Instruments, Inc. · 2011-07-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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