Events

Rappel de Device Recall Aquarius iNtuition Client Viewer

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 TeraRecon, Inc..

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
    70426
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1070-2015
  • Date de mise en oeuvre de l'événement
    2015-01-21
  • Date de publication de l'événement
    2015-02-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133581
  • 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
    System, image processing, radiological - Product Code LLZ
  • Cause
    Software anomaly related to recist1.1 target lesion evaluation criteria in findings workflow module within the aquarius intuition client viewer.
  • Action
    Medical Device Correction letters were sent to all affected users on January 21, 2015 by both e-mail and physical mail - certified mail for us customers and FEDEX for international customers.

Device

Device Recall Aquarius iNtuition Client Viewer
  • Modèle / numéro de série
    Serial numbers: AQ-UH6467, AQ-UH7694, AQ-UH8703, AQ-UN5993, AQ-UH8380, AQ-UH8481, AQ-UH8510, AQ-UH8511, AQ-UN5272, AQ-UH7183, AQ-UH5375, AQ-UN5266, AQ-UH6807, AQ-UH6915, AQ-UH8676, AQ-UN5143, AQ-UH8516, AQ-UN5234, AQ-UH7704, AQ-UH7705, AQ-UH7706, AQ-UH8197, AQ-UH8269, AQ-UN5247, AQ-UN5086, AQ-UN5256, AQ-UH8184, AQ-UH8454, AQ-UH8502, AQ-UH8614, AQ-UH8610, AQ-UH8609, AQ-UN5274, AQ-UN5273, AQ-UH8603, AQ-UH8597, AQ-UH8598, AQ-UN5163, AQ-UH3663, AQ-UH8309, AQ-UN5268, AQ-UN5269, AQ-UH8574, AQ-UH8575, AQ-UH8576, AQ-UH8365, AQ-UN5250, AQ-UH7862, AQ-UH7863, AQ-UH7864, AQ-UH8617, AQ-UH8551, AQ-UH8565, AQ-UH8586, AQ-UH8585, AQ-UN5267, AQ-UH8541, AQ-UN5261, AQ-UH8294, AQ-UN5260, AQ-UH8367, AQ-UH8684, AQ-UH2305, AQ-UH8489, AQ-UH5116, AQ-UN5275, AQ-UH8618, AQ-UH8054, AQ-UH7915, AQ-UH8040, AQ-UH4940, AQ-UH8486, AQ-UH8320, AQ-UH8321,AQ-UN5253, AQ-UH7156, AQ-UH7844, AQ-UH8666, AQ-UH7848, AQ-UN5115, AQ-UH8351, AQ-UH8352, AQ-UH8353, AQ-UH8354, AQ-UH8355, AQ-UH8214, AQ-UH7874, AQ-UH3098, AQ-UH8102, AQ-UN5113, AQ-UH8100
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.
  • Description du dispositif
    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: || Picture Archiving and Communications System; || Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. || A fully-configured iNtuition system is capable of various image processing and || visualization functions, including basic features and advanced post processing || modules. The system can be configured as a server with some, all, or none of its || optional features disabled. || The intended use of the device is to provide solutions to various medical || image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.
  • Manufacturer
    TeraRecon, Inc.

Manufacturer

TeraRecon, Inc.
  • Adresse du fabricant
    TeraRecon, Inc., 4000 E 3rd Ave Ste 200, Foster City CA 94404-4805
  • Société-mère du fabricant (2017)
    Terarecon Inc
  • Source
    USFDA