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    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

    COULTER LH 750 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LOQ·March 17, 2011

    COULTER® LH 750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·March 18, 2011

    COULTER® LH 750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·March 18, 2011

    COULTER® LH 750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 23, 2010

    COULTER ® LH750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·July 30, 2010

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·November 30, 2010

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·January 11, 2019

    COULTER® LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·January 3, 2011

    COULTER AC*T 5 DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·November 12, 2010

    COULTER AC*T 5 DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·November 12, 2010

    COULTER® LH 780

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 8, 2010

    COULTER ® LH750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·July 29, 2010

    COULTER ® LH750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·September 23, 2010

    COULTER ® LH750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·July 30, 2010

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·November 5, 2010

    DXC 600I

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 18, 2011

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·April 29, 2011

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·April 6, 2011

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·April 6, 2011