FDA recall, , High risk
BMC Luna G3 APAP Machines
The firmware defects could result in unintended serious adverse health consequences.
BMC Medical lists the affected products
Summary by Recall Canary from the FDA notice
What happened
The firmware version G3-2.00.76 installed on the Luna G3 Apap devices contains a defect. When the device operates under high pressure, high respiratory rate, and high peak flow simultaneously, it can display an error and shut down. No complaints or serious adverse reports have been received to date.
3 photos
What to do
If a code on your device is listed below:
- Continue using the device as prescribed and do not discontinue therapy before receiving a replacement.
- Contact your device provider, if you have not already heard from them, for replacement of your affected Luna G3 APAP (LG3600) device, firmware version: G3-2.00.76 with configuration G3 A20-31.cfg.
- Serial number be located in the following places: (See Images Below) Patients should contact their device provider, if they have not already heard from them, for replacement of their affected Luna G3 APAP (LG3600) device, firmware version: G3-2.00.76 with configuration G3 A20-31.cfg.
- For any inquiries, please contact RH, the U.S. importer of BMC, at telephone number 863-226-6285 or via email at 3B-Recall@
reacthealth.com, 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 bmc- recall@ bmc-medical.com.
Is yours affected?
BMC Medical lists the affected products on its website. A product missing from this page may still be recalled.
Look up your product on en.bmc-medical.com/rc-adh.html (opens in a new tab)
A UDI-DI is the device identifier printed with the barcode on the device label.
Luna G3 Apap (
- Model number
- LG3600)
- LG3600
- UDI-DI
- 06948538363331
- 06948538365892
- 124937331
Recall details
- Company announced
- Sold in
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. Impacted products were distributed nationwide between October 29, 2024, through July 6, 2026.
- Company
- BMC Medical Co., Ltd.
- Hazard
- Software defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
