BEUDAMED
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    Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex Cardio FC2010 Rev C 453564621791 Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021 Xper Flex Cardio 2010 Rev D 453564669081 Xper Flex Cardio 2010 Rev D Russia 453564674581 Xper Flex Cardio FC2010 Rev E 453564845841 Xper Flex Cardio 2010 Rev E Russia 453564845881 Service numbers associated with FC2020: Xper Flex Cardio 2020 Rev A 453564241911 Xper Flex Cardio 2020 Rev B 453564483331 Flex Cardio FC2020 Rev C 453564621801 Xper Flex Cardio 2020 Rev D 453564675001 Xper Flex Cardio FC2020 Rev E 453564845861 Software version number: 1.5.19 and 1.6.8

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MWI·March 29, 2021

    Welch Allyn Connex Spot Monitor

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code MWI·August 10, 2023

    McKesson Cardiology Hemo software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    Change Healthcare Cardiology Hemodynamics Software

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code MWI·May 22, 2025

    CLEO Patient Monitor /Tranquility VS Patient Monitor

    FDA Recall
    Open, Classified ·Infinium Medical, Inc·Product code MWI·May 31, 2019

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code MWI·August 21, 2024

    Change Healthcare Cardiology Hemodynamics software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No

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

    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MWI·September 6, 2022

    Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code MWI·March 21, 2025

    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

    FDA Recall
    Open, Classified ·Covidien LLC·Product code MWI·January 30, 2026

    Change Healthcare Cardiology Hemo software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    Welch Allyn CONNEX Accessory Power Management Stand:

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code MWI·March 24, 2025

    Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

    FDA Recall
    Open, Classified ·Invivo Corporation·Product code MWI·November 20, 2017

    Change Healthcare Cardiology Hemo Software

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code MWI·May 22, 2025

    Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MWI·December 6, 2024

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code MWI·May 2, 2024

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

    FDA Recall
    Open, Classified ·Biosense Webster, Inc.·Product code DYB·February 21, 2023