FDA-PR2026-09-07PROCESSING DEFECT

BMC Luna G3 APAP (Model LG3600) recalled for firmware defect causing therapy delivery failure

Nationwide distributionFood

What this means

BMC Medical Co., Ltd. recalled 20,160 Luna G3 APAP sleep apnea devices (Model LG3600) due to a firmware defect in version G3-2.00.76. Under certain high-pressure, high-breathing-rate conditions, affected devices can display an error message and shut down automatically, stopping therapy delivery. Most devices were corrected with a firmware upgrade, but up to 196 units may still contain the defective version.

  • Check your device's serial number on the rear label and visit https://en.bmc-medical.com/rc-adh.html to confirm your firmware version.
  • If your device has firmware version G3-2.00.76, contact your physician and DME provider immediately, or email React Health (the U.S. importer) at 3B-Recall@reacthealth.com to request a replacement.
  • Do not use the device if it contains the defective firmware version until you receive a replacement.

Product photos

Luna G3 APAP Nameplate Label
Luna G3 APAP Nameplate Label
Luna G3 APAP Package Label
Luna G3 APAP Package Label
SN Location - Rear of Device
SN Location - Rear of Device
The agency's original wording
Hazard

On July 15, 2026, BMC Medical Co., Ltd. (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. This corrective action was not reported to customers. O

Intended for
Adults
Illnesses reported
None reported

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bmc-medical-co-ltd-recalls-luna-g3-apap-model-lg3600-firmware-g3-20076-due-firmware-defect

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