BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) Devices with Firmware G3-2.00.76 Configured with G3 A20-31.cfg
- Date
- Sep 7, 2026
- Company
- BMC Medical Co., Ltd.
- Brand
- BMC
- Product
- Luna G3 APAP (Model LG3600)
- Reason
- The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect
- Hazard
- Other
- Source
- FDA
How to identify the product
- (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.
- BMC has identified that firmware version, G3-2.00.76 with configuration G3 A20-31.cfg installed on these Luna G3 APAP (Model LG3600) devices contained a debug code.
- When the device operated under all three extreme conditions simultaneously — high pressure, high respiratory rate, and high peak flow — the debug code was triggered and activated, causing the device to display an 'Error' message and shut down.
- Impacted products were manufactured from September 11, 2024, to October 18, 2024, and distributed by BMC to its U.S. importer, React Health (RH), from September 20, 2024, to October 19, 2024.
- Impacted products were distributed nationwide between October 29, 2024, through July 6, 2026.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.