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 […]
Tag: bmc medical
FDA Cites BMC Medical Over Unapproved G3X APAP, Undisclosed Design Changes to Luna Line
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 […]





