Events

Rappel de Device Recall MHITM2000/VERO

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 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.

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
    72991
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1244-2016
  • Date de mise en oeuvre de l'événement
    2015-12-15
  • Date de publication de l'événement
    2016-03-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142642
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    Due to operator console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "completed (or discontinued)" to "untreated" under specific conditions.
  • Action
    Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" if all the following conditions are met: (1) At least one patient has been treated on the day; (2) A major error occurs when VeroTM/MHI-TM2000 is operated in a mode, other than Clinical Mode, which means Daily Check Mode or Maintenance Mode. (3) The major error is NOT associated with a function that uses therapeutic/ MV radiation parameters, such as an error in Isocenter Check function, etc. Note 1: If the major error is associated with a function that uses therapeutic/MV radiation parameters, the problem that treatment completion status is changed will never occur. The Operator Console changes the treatment completion status in the course of processing the major error. Note 2: Although treatment completion status is changed to "Untreated", its delivered dose result has been correctly saved into R&V; System. It has not been lost. Advice on Actions by Customer/Users: 1. Please make sure to perform the operations as described below in case a major error occurred in a mode other than Clinical Mode. (1) Cancel the error. (2) Click [Clinical] button on the left of Operator Console screen. (3) Verify, on R&V; System screen, that treatment completion status of the patients who were treated on the day are all correct. The treatment completion status is indicated in different colors as follows depending on the status: Untreated: BLUE, Completed: GRAY, Discontinued: RED. Customers requiring support concerning this issue, please contact the Customer Service Representative: 1-800-597-5911 (Mon - Fri) or via email us.support@brainlab.com. If any other problem is detected, please stop operation and contact the Customer Service representative.

Device

Device Recall MHITM2000/VERO
  • Modèle / numéro de série
    Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
  • Description du dispositif
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) || Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
  • Manufacturer
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Manufacturer

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
  • Adresse du fabricant
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
  • Société-mère du fabricant (2017)
    Mitsubishi Heavy Industries Ltd.
  • Source
    USFDA