Events

Rappel de Device Recall Eclipse Oxygen 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 Sequal Technologies 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
    53952
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0567-2010
  • Date de mise en oeuvre de l'événement
    2009-10-01
  • Date de publication de l'événement
    2009-12-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86920
  • 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
    Portable Oxygen Generator - Product Code CAW
  • Cause
    Unit may shut down when operating from the power cartridge. a temporary power interruption would cause the unit to sound an alarm and shut down. if the patient does not have access to an alternate supply of oxygen or access to ac or dc power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.
  • Action
    The recall notification was initiated on November 12, 2009 with the firm forwarding a "Medical Device Correction" letter to all of the affected consignees via US Postal Service for US Consignees and FedEx for Foreign Consignees. The Medical Device Correction Letter contained the following: (1) Medical Device Correction Letter; (2) List of Serial Number affected that were distributed to the Provider; (3) Reply Card that the Provider will be requested to send back regarding receipt notification of the Medical Device Correction Letter and confirming that they have the affected product; (4) Additional Medical Device Correction Letters for Providers to distribute to their patients. The Medical Device Correction Letter informed the consignees of the reason for recall, the hazard involved and the actions that were required. For further details or information, consignees were instructed to contact SeQual Technical Support at 1-800-826-4610 from 8:00 AM to 5:00 PM PST.

Device

Device Recall Eclipse Oxygen System
  • Modèle / numéro de série
    Serial Numbers: All Serial Numbers affected for units manufactured June 2006 - January 2008.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Including countries of USA, ARGENTINA, AUSTRIA, BAHAMAS, BERMUDA, CANADA, CHILE, COLUMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, ITALY, ISRAEL,JAPAN, JORDAN, KUWAIT, MALTA, NETHERLANDS, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Description du dispositif
    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 || Indicated for the administration of supplemental oxygen.
  • Manufacturer
    Sequal Technologies Inc

Manufacturer

Sequal Technologies Inc
  • Adresse du fabricant
    Sequal Technologies Inc, 11436 Sorrento Valley Rd, San Diego CA 92121
  • Société-mère du fabricant (2017)
    Sequal Technologies
  • Source
    USFDA