BEUDAMED
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    SCREW TAP IMP. UNITITE Ø3.8MM

    FDA UDI
    Sin Sistema de Implante Nacional S/A·07899995293473·SCREW TAP IMP. UNITITE Ø3.8MM

    SCREW TAP IMP. UNITITEØ5.0MM

    FDA UDI
    Sin Sistema de Implante Nacional S/A·07899995278647·SCREW TAP IMP. UNITITEØ5.0MM

    SCREW TAP IMP. UNITITE Ø4.1MM

    FDA UDI
    Sin Sistema de Implante Nacional S/A·07899995256058·SCREW TAP IMP. UNITITE Ø4.1MM

    SCREW TAP IMP. UNITITE Ø5.5MM

    FDA UDI
    Sin Sistema de Implante Nacional S/A·07899995245397·SCREW TAP IMP. UNITITE Ø5.5MM

    NA

    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749045741·Atrium bracket for MRN-3 RA (Tricusp.) 18x35mm

    NA

    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749045789·Guiding clamp for atrial blade and retainer

    SCREW TAP IMP. UNITITE Ø4.5MM

    FDA UDI
    Sin Sistema de Implante Nacional S/A·07899995278500·SCREW TAP IMP. UNITITE Ø4.5MM

    MRU

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·April 17, 2019

    VALIDITY CHECK MR

    FDA UDI
    UTAK LABORATORIES, INC.·B800VALMRUUK0·VALIDITY CHECK MR

    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·January 7, 2015

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 21, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·July 8, 2019

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·July 25, 2019

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 22, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 9, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 11, 2012

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 18, 2013

    GE 1.5T SIGNA HDX MR SYSTEM

    FDA Adverse Event
    Death ·GE MEDICAL SYSTEMS, LLC·Product code LNH·November 2, 2021

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 14, 2012

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·April 13, 2018