BEUDAMED
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    HOSPITAL MATTRESS - CLC (12)

    FDA Adverse Event
    Malfunction ·OFF-LOADING TECHNOLOGIES, INC.·Product code IKY·January 2, 2025

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 12, 2013

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    FDA Adverse Event
    Malfunction ·NORTHGATE TECHNOLOGIES INC.·Product code FFK·December 23, 2021

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    FDA Adverse Event
    Malfunction ·NORTHGATE TECHNOLOGIES, INC·Product code FFK·September 15, 2021

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    HERCULES 360

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code MWS·August 26, 2015

    SLIDEPREP PLUS CYTOLOGY CENTRIFUGE

    FDA Adverse Event
    Malfunction ·SEPARATION TECHNOLOGY, INC. PART OF THERMO FISHER SCIENTIFIC·Product code IFB·August 16, 2012