Events

Rappel de Respironics Trilogy 100, 200, and 202 Ventilators

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 Respironics, 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
    62393
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2024-2012
  • Date de mise en oeuvre de l'événement
    2012-04-27
  • Date de publication de l'événement
    2012-07-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110401
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    The specified trilogy units are being recalled because of the potential for a faulty component in the power supply.
  • Action
    Respironics, Inc. began contacting its affected US customers by phone beginning on Friday, April 27, 2012, and requested that they quarantine any affected devices within their possession and that they retrieve any devices with patients and quarantine those as well. Replacement devices were to be provided to all affected customers. For questions customers should call 724-387-7651. For questions regarding this recall call 877-387-3311..

Device

Respironics Trilogy 100, 200, and 202 Ventilators
  • Modèle / numéro de série
    Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain.
  • Description du dispositif
    Respironics Trilogy 100, 200, and 202 Ventilators || The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Adresse du fabricant
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8517
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA