BMC Medical recalls 20,160 Luna G3 APAP devices over firmware defect, class I recall

BMC Medical Co., Ltd. announced a recall of its Luna G3 APAP (Model LG3600) devices that were distributed in the United States after identifying a firmware defect.

The defect was linked to firmware version G3-2.00.76 with a specific configuration that contained a debug code, leading the FDA to classify the recall as a Class I event.

BMC upgraded the firmware to version G3-2.00.77 for all 20,160 units at the U.S. importer’s warehouse between October and December 2024, though up to 196 devices may not have received the upgrade.

The company did not initially notify customers of the recall. A press release on October 1, 2026 later added more precise technical language and clarified patient guidance and health risk information.