BEUDAMED
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    IQECG

    FDA Adverse Event
    Malfunction ·BRENTWOOD MED TECHNOLOGY DBA MIDMARK DIAGNOSTICS GROUP·Product code DSI·May 17, 2010

    PAGEWRITER TOUCH CARDIOGRAPH

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DPS·September 28, 2009

    PAGEWRITER TOUCH CARDIOGRAPH

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DPS·July 30, 2009

    MIDMARK DIGITAL EKG

    FDA Adverse Event
    Malfunction ·MIDMARK·Product code DRT·May 13, 2010

    TRANSVENOUS PACEMAKER

    FDA Adverse Event
    Injury ·UNK·Product code LWS·January 13, 2022

    CONTEC TLC 5000 DYNAMIC ECG SYSTEMS

    FDA Adverse Event
    Malfunction ·CONTEC MEDICAL SYSTEMS CO., LTD.·Product code MLO·June 23, 2023

    ALARIS PUMP MODULE

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FRN·May 24, 2018

    INTELLIVUE MX750 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·January 31, 2022

    PAGEWRITER TOUCH CARDIOGRAPH

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DPS·January 6, 2017

    INTELLISPACE ECG SOFTWARE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DQK·May 30, 2017

    PAGEWRITER TC70 CARDIOGRAPH

    FDA Adverse Event
    Death ·PHILIPS NORTH AMERICA LLC·Product code DPS·June 28, 2022

    ELI380 ERGO WAM WLAN USB DICOM SEC AHA B

    FDA Adverse Event
    Injury ·MORTARA INSTRUMENT·Product code DPS·November 25, 2025

    CRYOCONSOLE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code OCL·October 23, 2024

    INTELLIVUE PATIENT MONITOR MX700

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·May 4, 2026

    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·June 27, 2012

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·LIVANOVA USA, INC.·Product code MUZ·March 9, 2020

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 14, 2016

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·February 28, 2023

    LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 14, 2016

    ARROW CVC KIT: 4-LUMEN 8.5FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·September 27, 2024