Events

Rappel de Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical XRay 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 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
    75575
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0680-2017
  • Date de mise en oeuvre de l'événement
    2016-10-27
  • 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=150838
  • 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
    Possible unintentional x-ray emission after users attempt early termination of the sequence.
  • Action
    The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 41 units located in the United States will consist of the following: 1. Shipments were stopped until a software correction was designed and validated. The software correction was designed by October 27, 2016, and was implemented on November 7, 2016 for all units that had not left the place of manufacture and for all new products. 2. The software correction will be made available to all distributors, sales personnel and users. Issue 1 is corrected by altering the behavior of the stop button and trigger such that they stop the current test and terminate the test sequence. To correct issue 2 the software will be modified to grey-out the Stop button during this very small period making it consistent with rest of the VANTA Start/Stop test UI paradigm. Both during user Start and Stop actions, users are shown a greyed button to acknowledge user Click and the button is un-greyed when the system completes the user operation. Both user operations typically take 100  400 milliseconds to complete. 3. All VANTA units in the United States are currently in the possession of Olympus or your distributors. No units are in the possession of users. 4. Olympus or its distributors will apply the software correction prior to delivering a VANTA system to any purchasers in the United States. For further questions, please call (781) 419-3900.

Device

Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical XRay System
  • Modèle / numéro de série
    Model - Vanta VCR
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.
  • Description du dispositif
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
  • 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