BEUDAMED
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    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 28, 2018

    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 28, 2018

    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LIX·January 29, 2018

    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LIX·January 29, 2018

    Ingenuity Core 128 728323

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 12, 2016

    Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 12, 2016

    Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 12, 2016

    Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 12, 2016

    Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 12, 2016

    Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 25, 2016

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 4, 2014

    Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 8, 2016

    Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2016

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2016

    Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2016

    Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2016

    Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2016

    Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 5, 2016

    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·March 6, 2014

    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland), Inc.·Product code MUJ·February 11, 2014