Events

Rappel de Device Recall Centricity Laboratory Core Lab

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
    64806
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0330-2014
  • Date de mise en oeuvre de l'événement
    2013-03-12
  • Date de publication de l'événement
    2013-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117105
  • 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
    Ge healthcare has become aware of a potential safety issue associated with the use of ge centricity laboratory where panel reflex does not occur if dip.Specimen is blank. panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) the ordered panel is a slave panel, and; 2) the panitem specimen group field of one or more of the ordered items on the ma.
  • Action
    GE Healtchare sent an Urgent Medical Device Correction letter dated March 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers review their workflows to determine whether this series of events could happen at their sites. Customers who self-identified this series of events as a possible workflow are recommended to contact their GE service representative for a software correction. These customers may also elect to identify master panels that may be re-routed ad hoc and then to ensure that the specimen group field is updated to NULL if currently set to blank. Customers with any questions about this issue are advised to contact their GE service representative or the GE Healthcare IT Help Desk: North America at tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-277-4468.

Device

Device Recall Centricity Laboratory Core Lab
  • Modèle / numéro de série
    Software Versions: 3.3, 4.0, 4.1
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.
  • Description du dispositif
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. || The Centricity Laboratory System product is designed 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. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
  • 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