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    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.

    FDA Recall
    Terminated ·Vitrolife Inc·Product code KTO·December 22, 2014

    QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·July 30, 2011

    QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·April 4, 2013

    QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·April 4, 2013

    STANLEY Healthcare Arial 54315 Network Manager

    FDA Recall
    Terminated ·Stanley Security Solutions Inc·Product code IQA·June 14, 2019

    Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·August 1, 2011

    TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code MUJ·January 26, 2011

    MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code LNH·October 15, 2012

    Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code MUJ·December 1, 2009

    MRIdian Linac Radiation Therapy System, Model 20000.

    FDA Recall
    Terminated ·Viewray, Inc.·Product code IYE·March 18, 2019

    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·February 17, 2010

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    FDA Recall
    Terminated ·Iba Dosimetry·Product code IYE·April 26, 2017

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 9, 2019

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Recall
    Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·August 20, 2013

    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

    FDA Recall
    Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·September 25, 2014

    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

    FDA Recall
    Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·December 10, 2015

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    FDA Recall
    Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·February 2, 2015

    Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

    FDA Recall
    Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code FAP·March 15, 2018

    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

    FDA Recall
    Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code CCT·March 19, 2018

    Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.

    FDA Recall
    Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BZA·March 27, 2018