Events

Rappel de Ventana Medical System's Symphony Staining 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 Ventana 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
    45437
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0300-2008
  • Date de mise en oeuvre de l'événement
    2007-09-06
  • Date de publication de l'événement
    2008-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-07-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65469
  • 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
    in vitro diagnostic - Product Code KEY
  • Cause
    Shock hazard: devices released prior to full testing; the configuration of the symphony instrument during hi pot testing procedures did not completely evaluate all components in the test loop. in specific circumstances, a shock hazard exists.
  • Action
    On 9/6/07, the firm began visiting customers to perform the HiPot test. Prior to performing the High Potential Test of Symphony Instruments already in the Field, the Field Service Engineer or FSE ensures that the customer fully understands the purpose of the test and why it is necessary to perform the test at their site. The FSE conveys the following points regarding the HiPot test: - The HiPot test is a safety verification for the electrical path within the instrument. - The HiPot test was performed incorrectly during the manufacturing process. - The HiPot test is used to verify that if a high voltage overload condition were to occur it would not lead to a short/arc within the instrument, which could pose a risk to anyone that touches the instrument - The HiPot test places a voltage of 2,000VDC onto the high voltage path of the instrument and if any of the insulating components are compromised, the tester will notify the FSE of the condition. - If the instrument fails the HiPot test, the faulty component will be replaced and the instrument will be retested until it passes. - Due to the high voltage used the during the test, no one will be allowed to touch the instrument until the test is complete. The FSE performing the test documents that the customer was informed of the reason for the High Potential Test on their Field Service Report.

Device

Ventana Medical System's Symphony Staining System
  • Modèle / numéro de série
    Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA, Japan and France
  • Description du dispositif
    Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Adresse du fabricant
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Source
    USFDA