Federal regulators have placed a widely distributed home sleep apnea machine in their most serious recall category, and up to 196 of the affected devices may still be running the defective software.
The Food and Drug Administration published the notice on September 8 covering 20,160 Luna G3 APAP units, model LG3600, manufactured by BMC Medical Co., Ltd. of Beijing. The agency classified the action as a Class I recall on August 19, the designation it reserves for problems that could cause serious injury or death.
