Events

Rappel de Device Recall MOSAIQ Oncology Information Systems

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 Impac Medical Systems 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
    62302
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1944-2012
  • Date de mise en oeuvre de l'événement
    2012-06-08
  • Date de publication de l'événement
    2012-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110188
  • 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
    Impac medical became aware of a problem with the recording of the wedge motor units in mosaiq when it resumes after a machine terminates/faults, the remaining wedge mu was being erroneously set to zero.
  • Action
    A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.

Device

Device Recall MOSAIQ Oncology Information Systems
  • Modèle / numéro de série
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
  • Description du dispositif
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. || An image enabled electronic medical record system used for oncology workflow management. || Manufactured by: || Impac Medical Systems || 100 Mathilda Place, 5th floor || Sunnyvale, Ca 94086
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Adresse du fabricant
    Impac Medical Systems Inc, 100 Mathilda Place, 5th Floor, Sunnyvale CA 94086-6076
  • Société-mère du fabricant (2017)
    Impac Medical Systems Inc
  • Source
    USFDA