SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.
This recall has been terminated (originally issued December 23, 2009).
- Company
- Sequal Technologies Inc
- Recall Initiated
- October 1, 2009
- Posted
- December 23, 2009
- Terminated
- June 18, 2012
- Recall Number
- Z-0567-2010
- Quantity
- 6,588 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Serial Numbers: All Serial Numbers affected for units manufactured June 2006 - January 2008.
Root Cause
Pending
Action Taken
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.