BEUDAMED
    39 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    SIGNA Excite 3T. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    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

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

    Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·April 21, 2023

    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·February 15, 2024

    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

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

    Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·April 21, 2023

    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·April 21, 2023

    Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·June 20, 2024

    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·February 15, 2024