BEUDAMED
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    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·December 25, 2013

    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSF·September 19, 2013

    GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013

    GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.

    FDA Recall
    Terminated ·GE Healthcare·Product code KPR·March 7, 2008

    GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 5, 2012

    GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 5, 2012

    GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 5, 2012

    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·September 28, 2007

    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·September 28, 2007

    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 25, 2012

    GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code IYO·October 22, 2009

    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 Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.

    FDA Recall
    Terminated ·GE Healthcare·Product code KPR·November 1, 2007

    GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 6, 2013

    GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 8, 2013

    GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010