Events

Rappel de Device Recall Nemio XG SSA580A, Diagnostic Ultrasound 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 Toshiba American Med Sys 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
    37813
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0771-2007
  • Date de mise en oeuvre de l'événement
    2006-12-19
  • Date de publication de l'événement
    2007-05-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51592
  • 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
    Diagnostic Ultrasound System - Product Code ITX
  • Cause
    Transducer surface temperature : it was found during testing that when using the system in the 2dcdi + pw mode, with the scale graph function active, that the transducer surface temperature could exceed the 27 degrees celsius limit as specified in the iec safety standard.
  • Action
    Notification letters were sent to customers on December 19, 2206. Customers were instructed to avoid using Scale Graph function with live images, and instructed to call up the Scale Graph after images are frozen. Customers were informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.

Device

Device Recall Nemio XG SSA580A, Diagnostic Ultrasound System
  • Modèle / numéro de série
    Serial #: A1A0642100; A1A0642102; A1B0662183; A1B0662184; A1B0662256; A1B0662257; A1B0662258; A1B0662327; A1B0662328; A1B0662330; A1B0662331; A3A0652115; A3B0662284; A3B0662285; A3B0662286; A3B0662287; A3B0662288; A3B0662289; A3B0662290; A3B0662291; A3B0662292; A3B0662293; A3B0662371; A3B0662372; A3B0662373; A3B0662374; A3B0662375; A3B0662376; A3B0662377; A3B0662378; A3B0662379; A3B0662380; A3B0672415; A3B0672416; A3B0672417; A3B0672418; A3B0672419;
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI.
  • Description du dispositif
    Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Adresse du fabricant
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA