BEUDAMED
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    GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company

    FDA Recall
    Terminated ·Datex Ohmeda, Inc·Product code BSZ·August 10, 2006

    GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.

    FDA Recall
    Terminated ·Datex Ohmeda, Inc·Product code CBK·February 2, 2007

    GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Recall
    Terminated ·Datex - Ohmeda, Inc·Product code BSZ·August 28, 2008

    GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BTL·June 26, 2012

    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

    Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FNL·November 11, 2008

    100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009