Events

Rappel de Device Recall Hitachi CXR4 CT (including SceptreP3 PET/CT)

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 Hitachi Medical Systems America 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
    35081
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1078-06
  • Date de mise en oeuvre de l'événement
    2006-02-21
  • Date de publication de l'événement
    2006-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-11-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45234
  • 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
    Tomography X-ray System - Product Code JAK
  • Cause
    The device has a software anomaly which affects the system's ability to create multiplanar reconstructions (mpr). some images from the resulting series do not display correctly, or display at all, when mpr was run on them.
  • Action
    Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006 and this correction will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.

Device

Device Recall Hitachi CXR4 CT (including SceptreP3 PET/CT)
  • Modèle / numéro de série
    Serial Number: CXR46201-46213 PC 46002-36011
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled MRI systems were distributed throughout the continental United States.
  • Description du dispositif
    Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Adresse du fabricant
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Société-mère du fabricant (2017)
    Hitachi Ltd
  • Source
    USFDA