Events

Recall of Device Recall Eclipse Oxygen System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sequal Technologies Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53952
  • Event Risk Class
    Class 2
  • Event Number
    Z-0567-2010
  • Event Initiated Date
    2009-10-01
  • Event Date Posted
    2009-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86920
  • Notes / Alerts
    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.
  • Extra notes in the data
    Portable Oxygen Generator - Product Code CAW
  • Reason
    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
  • Model / Serial
    Serial Numbers: All Serial Numbers affected for units manufactured June 2006 - January 2008.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 || Indicated for the administration of supplemental oxygen.
  • Manufacturer
    Sequal Technologies Inc

Manufacturer

Sequal Technologies Inc
  • Manufacturer Address
    Sequal Technologies Inc, 11436 Sorrento Valley Rd, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Sequal Technologies
  • Source
    USFDA