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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·July 17, 2019

    TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 3, 2021

    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·September 18, 2019

    EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·July 15, 2020

    TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 3, 2021

    Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

    FDA Enforcement
    Class II ·Terminated·Philips North America LLC·October 2, 2019

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020

    Poly G Integris H5000, System code 72246

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Allura CV20, system code 722031

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Cardio Vascular-Allura Centron, system code 722400

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·June 9, 2021

    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·September 18, 2019

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·July 15, 2020

    Integris Allura 9, system codes 722018 722021

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    HeartStart XL+ Defibrillator/Monitor, Model 861290

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·December 11, 2019

    UroDiagnost Eleva, system code 708033

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020