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    IntelliSpace Clinical Applications

    FDA UDI
    Philips Healthcare Informatics, Inc.·00884838091849·Philips IntelliSpace Clinical Applications is a...

    IntelliSpace PACS

    FDA UDI
    Philips Healthcare Informatics, Inc.·00884838074781·IntelliSpace PACS is an image management system...

    IntelliSpace Radiology

    FDA UDI
    Philips Healthcare Informatics, Inc.·00884838091740·IntelliSpace Radiology Software (client) is a s...

    AVALON FETAL MONITORS BY PHILIPS

    FDA Adverse Event
    Other ·PHILIPS·Product code HGM·December 27, 2010

    AVALON FETAL MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code HGM·May 28, 2011

    PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LLZ·July 27, 2011

    PHILIPS AVALON FM50

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE, INC.·Product code HGM·January 8, 2010

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INC.·Product code LLZ·June 9, 2010

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE INC.·Product code MKJ·April 15, 2013

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INC.·Product code LLZ·July 23, 2010

    SMARTMONITOR2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code NPF·December 8, 2014

    Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    SMARTMONITOR 2 WITH MODEM

    FDA Adverse Event
    Death ·CIRCADIANCE LLC·Product code FLS·September 30, 2015

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013

    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·August 22, 2012

    Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 20, 2012

    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 26, 2013

    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·July 18, 2012