BEUDAMED
    28 results · 22ms · Sources: EU EUDAMED, US FDA

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    Revolution CT

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·July 14, 2021

    Revolution CT

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code JAK·March 19, 2021

    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code DQK·March 16, 2022

    GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

    FDA Recall
    Completed ·DATEX--OHMEDA, INC.·Product code FMZ·June 6, 2023

    SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    Discovery MR750w 3.0T nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    SIGNA Voyager nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    SIGNA Architect nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    SIGNA Pioneer nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    SIGNA Premier nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    Optima MR450w 1.5T nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    SIGNA Artist nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    Discovery MR750 3.0T nuclear magnetic resonance imaging system

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LNH·August 26, 2021

    GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15) 2082844-001-01122391; 16) 2082844-001-01128579; 17) 2082844-001-01128725; 18) 2082844-001-01131573; 19) 2082844-001-01140642; 20) 2082844-001-01165870; 21) 2082844-001-100397; 22) 2082844-001-100676; 23) 2082844-001-100740; 24) 2082844-001-100743; 25) 2082844-001-100744; 26) 2082844-001-101075; 27) 2082844-001-101149; 28) 2082844-001-101199; 29) 2082844-001-101202; 30) 2082844-001-101203; 31) 2082844-001-101356; 32) 2082844-001-101366; 33) 2082844-001-101656; 34) 2082844-001-102136; 35) 2082844-001-102589; 36) 2082844-001-102858; 37) 2082844-001-526493; 38) 2082844-001-533346; 39) 2082844-001-570904; 40) 2082844-001-615985; 41) 2082844-001-616544; 42) 2082844-001-674814; 43) 2082844-001-701655; 44) 2082844-001-704407; 45) 2082844-001-709042; 46) 2082844-001-857748; 47) 2082844-001-888278; 48) 2082844-001-941288; 49) 2082844-001-965539; 50) 2082844-001-978713; 51) 2082844-001-982099; 52) 2082844-001-982310; 53) 2082844-001-982985; 54) 2082844-001-982988; 55) 2082844-001-983509; 56) 2082844-001-983643; 57) 2082844-001-983679; 58) 2082844-001-984096; 59) 2082844-001-984948; 60) 2082844-001-987480; 61) 2082844-001-987855; 62) 2082844-001-993967; 63) 2082844-001-994441; 64) 2082844-001-995782; 65) 2082844-001-998377; Radiant infant warmer

    FDA Recall
    Completed ·DATEX--OHMEDA, INC.·Product code FMZ·June 6, 2023

    VariCam

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·October 30, 2017

    Discover VH/Millennium VG Nuclear Medicine Imaging System

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·October 30, 2017

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·May 24, 2018

    Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LLZ·November 9, 2018

    Discovery NM/CT 670 ES, model 5376204-70-57

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·May 24, 2018