Events

Rappel de GE Centricity Ultra Laboratory System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare Integrated IT Solutions.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49517
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0472-2009
  • Date de mise en oeuvre de l'événement
    2008-09-22
  • Date de publication de l'événement
    2008-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73713
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Calculator/Data Processing Module for Clinical Use - Product Code JQP
  • Cause
    Software computer, error: the abnormal result flag is not being sent in the hl7 messages on results that are lower than the normal range. for further information, please telephone ge healthcare integrated it solutions at 800-437-1171.
  • Action
    GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled "PRODUCT SAFETY NOTIFICATION." The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.

Device

GE Centricity Ultra Laboratory System
  • Modèle / numéro de série
    Software versions 3.3.2.27_P4 and 4.0.1_SP.x
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Globally - United States including the states of New York and Texas; and the country of Canada.
  • Description du dispositif
    GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Adresse du fabricant
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA