BEUDAMED
    FDA Recall Terminated

    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

    Recall: Z-0567-2010 · Initiated October 1, 2009

    Recall

    Recall Number
    Z-0567-2010
    Event Number
    53952
    Firm
    Sequal Technologies Inc
    FEI Number
    1000519984
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    October 1, 2009
    Posted
    December 23, 2009
    Terminated
    June 18, 2012
    Address
    11436 Sorrento Valley Rd, San Diego, CA, 92121

    Description

    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

    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.

    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.

    Quantity

    6,588 units