Edan Diagnostics

12 recalls •

• Categories: Diagnostic Equipment, Infusion Pumps

Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No

Class I - Dangerous

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Oct 24, 2025 Diagnostic Equipment Nationwide View Details →

EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

Class I - Dangerous

Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

Nov 17, 2017 Infusion Pumps Nationwide View Details →

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).

Class I - Dangerous

Incorrect CO2 readings with some patient monitors.

Jun 23, 2016 Diagnostic Equipment Nationwide View Details →