Events

Rappel de Device Recall Centricity Enterprise Archive

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
    64761
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2739-2016
  • Date de mise en oeuvre de l'événement
    2012-11-16
  • Date de publication de l'événement
    2016-09-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117006
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • Cause
    There is a potential for data loss associated with empty path names resulting from hl-7 updates when the cache disk is almost full. in an unlikely event that the cache disk is almost full (<100mb) and hl-7 update events are received, the update action fails and an empty path name is written to the ea database. as a result the instance is not deleted from the storage device but no longer referenced. when trying to retrieve the instance an error is returned.
  • Action
    URGENT MEDICAL DEVICE CORRECTION letters dated November 16, 2012 and April 19, 2013, were sent to all affected customers.The letters requested that customers verify that all Enterprise Archive partitions have enough free space available and that the cache disk has at least 10% free space available. The letters further requested that customers whose disks are not being purged to the configured watermarks and the cache disk is almost full to contact their local GE service person. A permanent product correction (Service Pack 12 and release notes) will be provided by GE Healthcare IT. Customers with questions can contact their GE service representative or the GE Healthcare IT Remote Online Center Customer Care Center at 1-800-437-1171.

Device

Device Recall Centricity Enterprise Archive
  • Modèle / numéro de série
    Version: 3.0.x
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).
  • 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