A type of flow generators used for Sleep Apnea have been recalled by the FDA. Over 300,000 units manufactured by ResMed Inc. have been recalled. The device could short circuit at the power supply connector.
ResMed said patients can continue to use S8 flow generators until they receive a replacement unit but should immediately discontinue using the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or a charred odor.
ResMed’s S8 flow generators are distributed worldwide through medical equipment suppliers. Affected products can be identified by the serial number on the bottom of each device. A list of the recall’s serial numbers is available at resmed.com/en-us/s8program/s8program.html. Patients in the U.S. and Canada may also contact the company at 888-899-8991.
The devices are used worldwide. Patients outside of the U.S. and Canada can find contact information here resmed.com/s8program.