FDA Media Alert Detail

FDA Safety Alert

BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect

  • U.S. Food and Drug Administration
  • September 8, 2026
  • ID: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bmc-medical-co-ltd-recalls-luna-g3-apap-model-lg3600-firmware-g3-20076-due-firmware-defect

FDA MedWatch Safety Alert

On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers. O

Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.