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    ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Systems, Inc., 7905 Fuller Road, Eden Prairie, MN 55344, USA. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·November 10, 2008

    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications 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.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·September 19, 2013