Events

Rappel de Device Recall Shimadzu SONIALVISION G4 Xray TV 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 Shimadzu Medical Systems.

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
    75833
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0917-2017
  • Date de mise en oeuvre de l'événement
    2016-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151433
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Cause
    Shimadzu medical systems is recalling shimadzu x-ray tv system sonialvision due to possibility of oil leaking from the x-ray tube housing under certain conditions.
  • Action
    An urgent medical device recall notice and a field safety notice dated 11/20/16 was sent to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray TV System SONIALVISION G4. Shimadzu informed their customers that they have received a report that oil had leaked from X-ray tube device of SONIALVISION G4 during examination. Customers are informed of the description of the issue, the actions planned by Shimadzu to correct the issue, and the actions that should be taken by the customer. Customers are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

Device

Device Recall Shimadzu SONIALVISION G4 Xray TV System
  • Modèle / numéro de série
    Serial No. 41C351641002 41C351643001 41C351641003 41C351641001 41C351646001 41C351646002 41C351647001 41C35164A001 41C35164B001 41C35164C001 41C351651001 41C351651002  41C351653003 41C351653002 41C351653004 41C351653005 41C351654002 41C351655001 41C351655002 41C351655003 41C351656001  41C351659001 41C35165A001 41C35165A002 41C35165A003 41C35165B001 41C35165B002 41C351661001 41C351661002 41C351662001 41C351663001 41C351663002 41C351664001 41C351664002 41C351664004 41C351664005 41C351665001 41C351665003 41C351665002
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA
  • Description du dispositif
    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • Adresse du fabricant
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • Société-mère du fabricant (2017)
    Shimadzu Corp.
  • Source
    USFDA