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    CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Recall
    Terminated ·Winco Mfg., LLC·Product code INM·September 6, 2013

    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Recall
    Terminated ·Winco Mfg., LLC·Product code INM·September 6, 2013

    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Recall
    Terminated ·Winco Mfg., LLC·Product code INM·September 6, 2013

    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Recall
    Terminated ·Winco Mfg., LLC·Product code INM·September 6, 2013

    Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLLOWING APPLICATIONS IS INSTALLED: VesselIQ Xpress or AVA Xpress CardIQ Xpress Pro or Plus CardEP CardIQ Fusion PET or SPECT provided with Volume Viewer 3 and 3.1 from versions 7.0 to 7.5 and 8.1. To verify the version installed on your system: Select the Admin menu from the Patient list page. Then select Display Configuration. You will find the version of your system in Installed Application(s). This version will appear as vxtl_7.x or vxtl_8.x. Intended use: K993792: Smart Vessel Analysis (Smart VA) is a software post-processing option for the Advantage Workstation (AW) platform, which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization. K031261: Card EP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy. K041267: CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis II will run on the AW workstation, scanner operator console and PACS system. K061370: CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in severa

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 29, 2012

    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.

    FDA Recall
    Terminated ·Fenwal Inc·Product code CAC·March 5, 2019

    Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code BSZ·August 26, 2010

    Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code BSZ·August 26, 2010

    Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·February 14, 2022

    Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·December 16, 2021

    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·February 14, 2022

    Drager Surgical Lights Sola 500 and Sola 700.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FTD·August 26, 2009

    Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.

    FDA Recall
    Terminated ·Biorep Technologies·Product code DWS·March 19, 2014

    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·June 6, 2016

    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·May 31, 2016

    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019

    smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code CAT·July 6, 2018

    GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG

    FDA Recall
    Terminated ·General Electric Med Systems·Product code EAM·March 30, 2004

    Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019

    2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019