Events

Rappel de Device Recall GE Centricity Laboratory Software

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 It.

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
    55868
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2067-2010
  • Date de mise en oeuvre de l'événement
    2010-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92102
  • 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
    There is a potential safety issue associated with the use of ge centricity laboratory software where results from interfaced external reference laboratories are not displayed or stored correctly. this happens when the test is set up in centricity laboratory as a decimal (numeric) type result and the test result sent from the reference lab includes a comma in the result field.
  • Action
    The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated May 26, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue involving results from interfaced external reference laboratories that are not displayed or stored correctly if an unexpected alpha character is encountered in a result message that is expected to have a numeric value. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the result sent from the reference lab includes a comma in the result field. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to the their GE Service Representative or the GE Helpdesk at 888-778-3375.

Device

Device Recall GE Centricity Laboratory Software
  • Modèle / numéro de série
    All versions and releases
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: California, Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee and Texas, and internationally to Australia, Canada, China, England, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.
  • Description du dispositif
    GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.
  • Manufacturer
    Ge Healthcare It

Manufacturer

Ge Healthcare It
  • Adresse du fabricant
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA