BEUDAMED
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    HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·June 3, 2015

    HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTQ·March 5, 2015

    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·November 4, 2015

    MEVION S250 for Proton Radiation Therapy

    FDA Enforcement
    Class II ·Terminated·Mevion Medical Systems, Inc.·April 27, 2016

    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code MUJ·September 28, 2015

    ImagePilot, Model No. D9MA

    FDA Recall
    Terminated ·Konica Minolta Medical Imaging USA, Inc.·Product code LLZ·May 9, 2018

    CS-7, Model No. A4C1

    FDA Recall
    Terminated ·Konica Minolta Medical Imaging USA, Inc.·Product code MQB·May 9, 2018

    Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.

    FDA Recall
    Terminated ·Philips Medical Systems Sales & Service Region No. America·Product code KPR·December 1, 2004

    Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811

    FDA Recall
    Terminated ·Philips Medical Systems Sales & Service Region No. America·Product code KPR·December 1, 2004

    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 5, 2012

    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·August 15, 2012

    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·December 26, 2012

    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·June 3, 2015

    AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 13, 2015

    Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·February 21, 2018

    Storz Documentation Cart with Articulating Arm, Model Number 9601F

    FDA Recall
    Terminated ·Karl Storz Endoscopy America Inc 600 Corporate Pointe·Product code KOG·March 10, 2006

    BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

    FDA Enforcement
    Class II ·Terminated·Biocare Medical, LLC·April 7, 2021

    Multitom RAX with software version VF10

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021

    GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·July 25, 2011

    GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·April 16, 2009