BMC Medical recalls more than 20K Luna APAP devices due to firmware defect

WASHINGTON – BMC Medical retrospectively reported to the U.S. Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP devices (model LG3600) distributed in the United States due to a firmware defect, the agency has reported.

The FDA has classified it as a Class I recall (FDA Recall Number: Z-2979-2026).

BMC has identified that the firmware version G3-2.00.76 with configuration G3 A20-31.cfg that is installed on these Luna devices contained a debug code. The company conducted a firmware upgrade to version G3-2.00.77 for 20,160 affected devices at the U.S. importer’s warehouse from October through December 2024.

After reporting the retrospective recall, BMC discovered that up to 196 units cannot be confirmed to have received the upgrade. 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.

Patients should continue using the device as prescribed and should not discontinue therapy before receiving a replacement. To date, BMC has received no complaints or serious adverse reports associated with this debug error.

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

• Related reading: Earlier this year, the FDA issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices. Through an inspection, the agency determined that BMC made significant design and software changes to a previously cleared Luna APAP device without submitting a new 510(k) premarket notification for FDA review.