38 results · 61ms · Sources: EU EUDAMED, US FDA

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SYSMEX XE-2100

FDA Adverse Event
Malfunction ·SYSMEX AMERICA, INC·Product code GKZ·February 23, 2010

SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)

FDA Adverse Event
Malfunction ·SYSMEX AMERICA INC.·Product code OUG·September 11, 2015

HEMATOLOGY ANALYZER

FDA Adverse Event
Other ·SYSMEX AMERICA, INC.·Product code GKZ·March 1, 2004

SYSMEX WORK AREA MANAGER (WAM)

FDA Adverse Event
Malfunction ·SYSMEX AMERICA, INC.·Product code OUG·March 28, 2012

SYSMEX WORK AREA MANAGER SYSTEM

FDA Adverse Event
Malfunction ·SYSMEX AMERICA INC.·Product code OUG·September 10, 2015

SYSMEX XT

FDA Adverse Event
Malfunction ·SYSMEX AMERICA, INC.·Product code GKL·April 10, 2007

UDM-IPU

FDA Adverse Event
Malfunction ·SYSMEX AMERICA INC.·Product code OUG·July 1, 2024

SYSMEX UF-1000I

FDA Adverse Event
SYSMEX AMERICA, INC.·Product code LKM·February 6, 2014

SYSMEX XN-10

FDA Adverse Event
Malfunction ·SYSMEX AMERICA INC.·Product code GKZ·September 22, 2014

CARESPHERE WORKFLOW SOLUTION

FDA Adverse Event
Malfunction ·SYSMEX AMERICA INC.·Product code JQP·February 9, 2023

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FDA Adverse Event
Malfunction ·SYSMEX AMERICA, INC.·Product code GKZ·March 20, 2009

SYSMEX

FDA Adverse Event
Malfunction ·SYSMEX AMERICA, INC.·Product code GKZ·March 15, 2016

SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)

FDA Adverse Event
Injury ·SYSMEX AMERICA INC.·Product code OUG·March 10, 2016

SYSMEX WORK AREA MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·SYSMEX AMERICA INC.·Product code OUG·January 29, 2016

SYSMEX WORK AREA MANAGER SYSTEM

FDA Adverse Event
Injury ·SYSMEX AMERICA INC.·Product code OUG·January 12, 2017

XN HEMATOLOGY ANALYZER SORTER

FDA Adverse Event
Injury ·SYSMEX AMERICA, INC.·Product code GKZ·December 30, 2024

SYSMEX WORK AREA MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·SYSMEX AMERICA INC.·Product code OUG·April 21, 2016

SYSMEX WORK AREA MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·SYSMEX AMERICA INC.·Product code OUG·March 17, 2020

SYSMEX HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·SYSMEX AMERICA, INC.·Product code GKZ·November 3, 2023

SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)

FDA Adverse Event
Other ·SYSMEX AMERICA INC.·Product code GKZ·October 16, 2013