FDA WARNING_LETTER - BMC Medical Co., Ltd. - December 10, 2025

The FDA issued a Warning Letter to BMC Medical Co., Ltd. following an inspection conducted from December 1 to December 10, 2025. The investigation determined that the company is marketing modified ventilator devices, specifically the G3X APAP model, without the necessary regulatory clearance. The primary violation involves significant design, hardware, and software modifications made to the previously cleared Luna CPAP and APAP systems. These changes include updated algorithms for detecting breathing events, hardware updates to the circuit board, and modifications to sound-reduction materials. Under the Federal Food, Drug, and Cosmetic Act, these changes require a new premarket notification because they could significantly impact device safety and effectiveness. Marketing these products without such clearance renders them unapproved and misbranded. Additionally, BMC failed to report a mandatory medical device correction to the FDA. The company updated device firmware to address a defect that caused unexpected shutdowns and a loss of therapy for patients. Federal regulations require companies to report such safety-related corrections within ten business days, which the company failed to do. To resolve these issues, the FDA requires BMC Medical to provide a written response within 15 business days. This response must outline specific steps taken to address the violations, provide documentation of corrective actions, and detail a plan to prevent recurrence. The company was also reminded that any manufacturing improvements must now comply with the updated Quality Management System Regulation (QMSR).