Events

Rappel de Device Recall Analytical XRay Fluorescence Systems of model family Delta

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 Olympus Scientific Solutions Americas.

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
    74593
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2255-2016
  • Date de mise en oeuvre de l'événement
    2016-06-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148001
  • 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
    X-ray fluorescence - Product Code RBY
  • Cause
    Trigger lock option does not always prevent x-ray generation. specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. the correction is via repair by a software update.
  • Action
    The firm notified customers via an "Important - Electronic Product Radiation Warning" letter. It described the issue; and, told customers to not rely on the Trigger Lock feature until the software upgrade had been completed. The letter also provided instructions for customers to not only determine their software version; but, also instructions to bring their affected device into compliance. The firm will remedy the issue without charge. Customers can contact their local representative or OSSA at ani.technicalsupport@olympus-ossa.com, phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.

Device

Device Recall Analytical XRay Fluorescence Systems of model family Delta
  • Modèle / numéro de série
    All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. || Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.
  • Manufacturer
    Olympus Scientific Solutions Americas

Manufacturer

Olympus Scientific Solutions Americas
  • Adresse du fabricant
    Olympus Scientific Solutions Americas, 48 Woerd Ave, Waltham MA 02453-3824
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA