ResMed Recalls Certain 58 Sleep Flow Generators
Sleep Apnea Product Recall
ResMed 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.
ResMed voluntarily recalled the product after learning that in rare instances