BEUDAMED
    165 results · 57ms · Sources: EU EUDAMED, US FDA

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    9100-SERIES

    FDA Adverse Event
    Injury ·GETINGE DISINFECTION AB·Product code MEC·March 10, 2017

    ALM

    FDA Adverse Event
    Other ·GETINGE USA, INC [F.K.A. ALM SURGICAL EQUIP (CA)]·Product code FSY·May 29, 2007

    88-SERIES

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·April 11, 2017

    9100-SERIES

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·February 2, 2017

    *

    FDA Adverse Event
    Other ·MAQUET S.A.·Product code BYX·August 21, 2007

    9710055-2007-00024

    FDA Adverse Event
    Other ·Product code FSY·November 9, 2007

    ALM

    FDA Adverse Event
    Other ·MAQUET S.A.·Product code FSY·July 20, 2007

    TORNADO

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code FLH·October 11, 2017

    533HC

    FDA Adverse Event
    Injury ·GETINGE IC PRODUCTION POLAND SP. Z.O.O.·Product code FLE·December 5, 2017

    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.

    FDA Enforcement
    Class II ·Terminated·Getinge USA Inc·August 28, 2013

    86-SERIES

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·October 19, 2017

    CM320

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·July 26, 2017

    88-SERIES

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·October 10, 2017

    9100-SERIES

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·December 4, 2017

    GETINGE 86 SERIES WASHER DISINFECTOR

    FDA Adverse Event
    Injury ·GETINGE DISINFECTION AB·Product code MEC·January 24, 2017

    9100-SERIES WASHER DISINFECTOR

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·June 17, 2017

    9100-SERIES WASHER DISINFECTOR

    FDA Adverse Event
    Malfunction ·GETINGE DISINFECTION AB·Product code MEC·June 17, 2017

    MAQUET

    FDA Adverse Event
    Malfunction ·GETINGE USA, INC.·Product code FQO·March 4, 2009

    STERILIZER

    FDA Adverse Event
    Malfunction ·GETINGE USA, INC.·Product code FLE·February 25, 2004

    STERILIZER, STEAM

    FDA Adverse Event
    Malfunction ·GETINGE USA, INC.·Product code FLE·October 13, 2017