The Magazine for Sleep Professionals
Sunday, October 11, 2026
BMC Medical Co., Ltd. has recalled its Luna G3 APAP device (model LG3600) due to a firmware defect that can cause the machine to display an error message and shut down automatically, cutting off therapy delivery, the U.S. Food and Drug Administration announced. The FDA has classified the action as […]
The FDA has issued a warning letter to BMC Medical Co., Ltd., the Beijing-based manufacturer behind the Luna and G3X lines of CPAP and APAP devices sold in the U.S. through distributor 3B Medical (doing business as React Health) of Dublin, Ohio. The letter, dated May 20, 2026, stems from […]
3B Medical, Inc. has received FDA 510(k) clearance on its new third-generation bi-level device, the Luna G3 Auto-BPAP. The Luna G3 Auto BPAP is a modern and technologically advanced Bi-Level PAP therapy device for the treatment of obstructive sleep apnea. This device is available with integrated heated tubing, cellular connectivity […]
