Events

Rappel de Device Recall VERO Linear Accelerator 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 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
    68909
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2653-2014
  • Date de mise en oeuvre de l'événement
    2014-07-05
  • Date de publication de l'événement
    2014-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128998
  • 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
    Software anomaly: if a user changes the calendar setting from workday to holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become treated (completed) status on the exact day when such change is made, to untreated status. furthermore, such treatment would be cloned and mistakenly added to the schedule as untreated treatment.
  • Action
    A Preliminary Customer Information Letter (dated 7/4/14) was emailed to customers on 7/05/14 from Mitsubishi's sales and service representative in Germany. The letter informed customers of the potential safety issue associated with the VERO Linear Accelerator and the recommended actions to be taken. A formal URGENT FIELD SAFETY NOTICE Letter (dated 7/15/14) was emailed to customers on 8/07/14 from Mitsubishi's sales and service representative in Germany. The letter instructed customers to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions to be taken.

Device

Device Recall VERO Linear Accelerator System
  • Modèle / numéro de série
    Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of NY, FL, and TX.
  • Description du dispositif
    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment 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