2026.10.02
Medical Device Recall (Z-2979-2026) News Release
UPDATEDBMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) device with Firmware G3-2.00.76 configured with G3 A20-31.cfg. FOR IMMEDIATE RELEASE: October 1st, 2026 Company AddressBMC Medical Co., Ltd. Room 10, 17F Building 4, Huiya Plaza, No.16 Lize Road, Fengtai District, Beijing 100073, CHINATelephone/Company Website+86-10-5166 3880/https://en.bmc-medical.com/U.S. Importer (React Health) Telephone1-863-226-6285Media Inquiry Contactemail: bmc-recall@bmc-medical.comOn 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. On August 19, 2026, the FDA classified this retrospective recall as a Class I recall (FDA Recall Number: Z-2979-2026). BMC has identified that firmware version, G3-2.00.76 with configuration G3 A20-31.cfg installed on these Luna G3 APAP (Model LG3600) devices contained a debug code. BMC conducted a firmware upgrade of these devices 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 September 11, 2024, to October 18, 2024, and distributed by BMC to its U.S. importer, React Health (RH), from September 20, 2024, to October 19, 2024. Impacted products were distributed nationwide between October 29, 2024, through July 6, 2026.Affected Products: Product Name: Luna G3 APAP Model: LG3600 UDI: 06948538363331; 06948538365892Affected Firmware Version: G3-2.00.76 with configuration G3 A20-31.cfgUsers of the Luna G3 APAP (Model LG3600) who have the device can check the status of their device by inputting their serial number at: https://en.bmc-medical.com/rc-adh.htmlSerial number be located in the following places: 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.Patients should continue using the device as prescribed and should not discontinue therapy before receiving a replacement.The recall notification can be seen at the following link:<Recall Notification>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 If an adverse reactions or quality problem has been experienced with the use of this product, it may be reported using one of the following options:· Phone:1-800-332-1088· Online: By completing and submitting the report online at https://www.accessdata.fda.gov/scripts/medwatch· Regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.
