FDAnews Device Daily Bulletin

ResMed Recalls 300,000 Sleep Apnea Devices

April 26, 2007

ResMed and the FDA announced a worldwide recall of approximately 300,000 S8 flow generators for the treatment of obstructive sleep apnea.

In S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector, the FDA said.

ResMed said it would work with its distribution partners to provide replacement devices to patients who have affected S8 flow generators.

The agency noted that patients may continue to use their S8 flow generators until they receive replacements, but should discontinue use of the devices if there are any signs of electrical failure, such as intermittent power, cracking sounds, sparking or a charred smell. Patients should not use supplemental oxygen with the S8 devices, the agency said.

More information can be viewed at: www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed