Z-0567-2010

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

Name: Z-0567-2010 SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental...
Creator: Sequal Technologies Inc
Published: 2009-10-01
License: https://open.fda.gov/license/

Sequal Technologies, Inc. / initiated 2009-10-01 / Terminated

FDA source

Sequal Technologies Inc began a recall of SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen on 2009-10-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0567-2010
Status: Terminated
Initiated: 2009-10-01
Posted: 2009-12-23
Terminated: 2012-06-18
Recalling firm: Sequal Technologies, Inc.
Product: SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: 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.
FDA root cause: Pending
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.
Quantity in commerce: 6,588 units
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 codes and lots: Serial Numbers: All Serial Numbers affected for units manufactured June 2006 - January 2008.

Product code CAW

K013931Class IIOmni Oxygen System, Model 1000Sequal Technologies, Inc. / cleared 2002-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)