BMC Medical recalls 20,160 Luna G3 APAP devices over firmware defect
On July 15 2026 BMC Medical Co., Ltd. in Beijing reported to the FDA a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States because the installed firmware version G3-2.00.76 contained a defect.
The FDA classified the recall as Class I on August 19 2026 (Recall Number Z-2979-2026). BMC performed a firmware upgrade to version G3-2.00.77 for the affected units at the U.S. importer’s warehouse between October and December 2024.
After the retrospective recall, BMC found that up to 196 units may not have received the upgrade and could still run the defective firmware. If those devices operate under high pressure, high respiratory rate, and high peak flow, they may display an "Error" message.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect”
read at fda medwatch ↗
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