According to an FDA alert, BMC Medical Co Ltd (BMC, Beijing China) retrospectively reported a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect.

The FDA says this corrective action was not reported to customers and on August 19, 2026 the agency classified it as a Class I recall (FDA Recall Number: Z-2979-2026).

BMC has identified that firmware version, G3-2.00.76 installed on these Luna G3 APAP (Model LG3600) devices contained a firmware defect. BMC conducted a firmware upgrade of these devices to version G3-2.00.77 for 20,160 affected devices at the US importer’s warehouse from October through December 2024. After reporting the retrospective recall, BMC discovered that potentially up to 196 units did not receive the upgrade and identified that these devices may still contain firmware version G3-2.00.76.

If the affected device(s) operates simultaneously under high pressure, high respiratory rate, and high peak flow an “Error” message on the device display is triggered, followed by automatic shutdown resulting in a failure to deliver therapy.

The firmware defects could result in unintended serious adverse health consequences. To date, BMC has received no complaints or serious adverse reports associated with this firmware failure.

Affected Products

Impacted products were manufactured from September 11, 2024, to October 18, 2024, and distributed by BMC to its US importer, React Health, from September 20, 2024, to October 19, 2024. Impacted products were distributed nationwide between October 29, 2024, through July 6, 2026.

Product Name: Luna G3 APAP
Model: LG3600
UDI: 06948538363331; 06948538365892
Affected Firmware Version: G3-2.00.76
Affected Serial Numbers: https://en.bmc-medical.com/rc-adh.html

FDA Recommendations

Users of the Luna G3 APAP (Model LG3600) who have the device can check their firmware version by:

  • Obtain the device SN (please locate the SN from the label on the rear of the device as shown in the figure below) → Access the inquiry webpage (https://en.bmc-medical.com/rc-adh.html) → Enter the SN (input the obtained SN in the “Serial Number(SN)” box at the top of the webpage) → Click “Check My Device” to perform the query → Obtain the firmware version of the device
  • Consulting their physician and Durable Medical Equipment (DME) provider to confirm if their Luna G3 APAP (LG3600, firmware version is safe to use.
  • Alternately, customer should contact React Health (RH), the US Importer for BMC, via email at: [email protected] for replacement of the uncorrected Luna G3 APAP (LG3600) device, firmware version: G3-2.00.76 with a new device for the prescribed therapy.

Affected devices operating with version G3-2.00-76 should be discontinued immediately until a replacement device is provided.

For any inquiries, please contact RH, the U.S. importer of BMC, at telephone number 863-226-6285 or via email at [email protected], Monday through Friday, between 8:00 a.m. and 5:00 p.m. Eastern Time (ET). Additionally, BMC may be reached at any time by email at [email protected].