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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

    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

    Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

    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

    Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

    Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

    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

    Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·June 20, 2024

    Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·April 11, 2024

    Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·September 25, 2023

    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

    Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·June 20, 2024

    Ascom Telligence Nurse Call System

    FDA Recall
    Open, Classified ·Ascom (US) Inc.·Product code IQA·November 2, 2018

    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·February 6, 2023

    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

    Senior Living Arial Emergency and Nurse Call Systems

    FDA Recall
    Open, Classified ·Stanley Security Solutions Inc·Product code IQA·November 17, 2021

    Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·November 1, 2024

    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