BMC Luna G3 APAP Recall: Firmware Defect Forces Therapy Shutdown
BMC Medical Co., Ltd. is recalling select Luna G3 APAP sleep-therapy devices (Model LG3600) because firmware version G3-2.00.76 can display an error message and power the machine off. This Class I recall covers 20,160 units distributed in the United States between and . If your Luna G3 APAP runs firmware G3-2.00.76, stop using it immediately and request a free replacement from React Health, the U.S. importer.
BMC Luna G3 APAP recall quick facts
- Hazard — Firmware G3-2.00.76 may trigger an “Error” message and shut the device down, stopping therapy mid-use.
- Units recalled — 20,160 devices; approximately 196 are estimated to remain in service with the faulty firmware.
- Manufacturing window — September 11 2022 – October 18 2022.
- User action — Check your serial number online and discontinue use if the lookup shows firmware G3-2.00.76.
- Remedy — React Health will supply a replacement Luna G3 APAP running firmware G3-2.00.77 or newer at no cost.
Sources
How to confirm whether your Luna G3 APAP is affected
- Locate the serial number on the rear label of the device.
- Visit the BMC recall-lookup page.
- Enter your serial number and click “Check My Device.”
- If the tool reports firmware G3-2.00.76, discontinue use and arrange a replacement.
Need help? Contact your physician or Durable Medical Equipment (DME) provider, or email React Health at 3B-Recall@reacthealth.com.
Replacement and customer support
If your device is part of the recall, request a replacement through React Health:
- Email: 3B-Recall@reacthealth.com
- Phone: 863-226-6285 (Mon–Fri, 8 a.m.–5 p.m. ET)
React Health will ship a new Luna G3 APAP running firmware G3-2.00.77 or later, free of charge.
How to report problems to FDA MedWatch
No injuries have been reported to date. If you experience an adverse event with a recalled Luna G3 APAP, report it to the FDA:
- Phone: 1-800-332-1088
- Online: MedWatch reporting form
- Mail/Fax: Download Form 3500 at FDA MedWatch and submit as directed.
Recall images
Frequently asked questions about the BMC Luna G3 APAP recall
Why is the BMC Luna G3 APAP being recalled?
Firmware version G3-2.00.76 can force the device to shut down during therapy, posing a risk of untreated sleep apnea.
Which Luna G3 APAP serial numbers are linked to the faulty firmware?
The recall covers 20,160 units distributed in the U.S. between October 2022 and April 2023. Use BMC’s online lookup to verify your specific serial number.
How can I check my BMC Luna G3 APAP firmware version?
Enter the serial number on the recall-lookup page or ask your DME provider to pull the firmware version from the device menu.
Is it safe to keep using my BMC Luna G3 APAP until I receive a replacement?
No. If the lookup shows firmware G3-2.00.76, power the device off and switch to an alternative treatment (e.g., backup CPAP or oral appliance) until your replacement arrives.
What replacement options does React Health offer for the Luna G3 APAP recall?
React Health will ship a brand-new Luna G3 APAP with updated firmware (G3-2.00.77 or newer) to affected users at no cost, including prepaid return labels for the recalled unit.
Will my insurance be billed for the new Luna G3 APAP after the recall?
No. The recall remedy is provided free of charge and does not affect your insurance benefits or coverage limits.
How do I report a problem with a recalled Luna G3 APAP to the FDA?
Submit an online report through MedWatch, call 1-800-332-1088, or mail/fax FDA Form 3500.