S8 program

S8 Program

Global Press Release (PDF)

ResMed Issues a Voluntary Recall for Certain S8 Flow Generators

FOR IMMEDIATE RELEASE – San Diego, CA, April 23, 2007 – ResMed today announced a worldwide voluntary recall of approximately 300,000 of its early production S8 flow generators used for the treatment of obstructive sleep apnea. In S8 devices manufactured between July 2004 and May 15, 2006, there is a remote potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator.

Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement.

The recall includes the following serial number ranges for all S8 models:

From To
20040285613 20060269563
20060275728 20060276751
20060277160 2006027741
20060281672 20060281991
20060283424 20060283743
20060284896 20060285445
20060287568 20060290823
20060292360 20060294694
20060312361 20060312597
20060318692 20060319459
20060325074 20060327794
20060330588 20060331043

 

For further details, choose your country and language from the following list:

Americas

United States and Canada - English

Canada - French

Latin America - Spanish

Brazil - Portuguese

Europe

Austria

Finland

France

Germany

Netherlands

Norway

Sweden

Switzerland

UK and Ireland

Asia Pacific

Australia

China

Hong Kong

India

Indonesia

Korea

Malaysia

Singapore

Taiwan

Thailand

Vietnam

Other Asia Pacific

If you purchased your device in a different country from where you currently live, check the table below, to confirm if you have an affected product.

Global serial numbers:

From To
20040285613 20060269563
20060275728 20060276751
20060277160 20060277415
20060281672 20060281991
20060283424 20060283743
20060284896 20060285445
20060287568 20060290823
20060292360 20060294694
20060312361 20060312597
20060318692 20060319459
20060325074 20060327794
20060330588 20060331043

If you have an affected product and no longer live in the country from where you purchased the device, click on the country link above for the country you now live in, for more information.