4/30/07
ResMed has initiated a voluntary worldwide recall of approximately 300,000 S8 flow generators used for treating obstructive sleep apnea.
The continuous positive air pressure devices manufactured between July 2004 and May 15, 2006 have a potential for a short circuit in the power supply connector.
Patients can use their S8 flow generators until they receive a replacement device but are warned against using supplemental oxygen with the unit. At the first signs of electrical failure such as intermittent power, cracking sounds, sparking, or a charred smell the company warns against further use.
The company will work with its distribution partners to provide replacement devices to patients with the affected units.
For a list of serial numbers of affected units, visit the FDA Web site.
