BEUDAMED
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    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Recall
    Completed ·Philips Healthcare Informatics, Inc.·Product code LLZ·April 19, 2019

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·May 24, 2018

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Recall
    Completed ·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020

    Infusion Pump

    FDA Recall
    Completed ·Baxter Healthcare Corporation·Product code FRN·January 6, 2021

    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    FDA Recall
    Completed ·Abbott Diabetes Care, Inc.·Product code QLG·February 9, 2023

    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

    FDA Recall
    Completed ·Iotamotion Inc·Product code QQH·September 12, 2024

    VariCam

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·October 30, 2017

    Discovery NM/CT 670 ES, model 5376204-70-57

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·May 24, 2018

    Discover VH/Millennium VG Nuclear Medicine Imaging System

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·October 30, 2017

    Discovery NM/CT 670 Pro, model 5376204-70-54

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·May 24, 2018

    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4

    FDA Recall
    Completed ·Cytrellis Biosystems, Inc.·Product code QAI·April 7, 2023

    Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Recall
    Completed ·Philips North America Llc·Product code LNH·August 11, 2021