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    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system

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

    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 12, 2014

    ITW Dymon Medaphene Plus Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 34720. The firm name on the label is ITW Dymon, Olathe, KS. The product is also sold under the following private labels: (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    ITW Dymon Medaphene Plus Orange Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 52920. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) O.D.S. Orange Disinfectant Spray, Continental Research Corporation, St. Louis, MO; (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation, Vernon Hills, IL; (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies, Tulsa, OK, Newburgh, IN, and Hopkinsville, KY; (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products, Cleveland, OH; (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply, Cape Girardeau, MO; (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries, Conway, AR; (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc., Norwood, MA; (8) Meyer Tri Power, Sold By Meyer Laboratory Inc., Blue Springs, MO; (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc., Irving, TX; (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company, St. Louis, MO; (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc., Alpharetta, GA; (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc., Elmhurst, IL; (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Phoenix, AZ.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    ITW Dymon Medaphene Plus Country Garden Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #42620. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL; (2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL; (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC; (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA; (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO; (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH; (8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI; (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL; (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY; (12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO; (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY; (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO; (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR; (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL; (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ; (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV; (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL. One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.

    FDA Recall
    Terminated ·ITW Dymon·February 15, 2005

    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

    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

    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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 20, 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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 26, 2012

    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

    FDA Recall
    Terminated ·Sequal Technologies Inc·Product code CAW·October 1, 2009

    BIT 9733516 2.9mm DRILL STERILE

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014

    INSTRUMENT TRACKER 9733533XOM ENT 1PK

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014

    Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.

    FDA Recall
    Terminated ·System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140·Product code CAW·May 1, 2003

    Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

    FDA Recall
    Terminated ·Stryker Instruments, Instruments Div.·Product code HAW·July 14, 2004

    Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.

    FDA Recall
    Terminated ·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010

    HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.

    FDA Recall
    Terminated ·Invacare Corporation·Product code CAW·January 11, 2011

    Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code HAW·June 11, 2014

    Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·February 6, 2012

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·November 13, 2012