Summary
Company Announcement
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. 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 installed on these Luna G3 APAP (Model LG3600) devices contained a firmware defect. 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 potentially up to 196 units did not receive the upgrade and identified that these devices may still contain firmware version G3-2.00.76.
If the affected device(s) operates simultaneously under high pressure, high respiratory rate, and high peak flow an "Error" message on the device display is triggered, followed by automatic shutdown resulting in a failure to deliver therapy.
The firmware defects could result in unintended serious adverse health consequences. To date, BMC has received no complaints or serious adverse reports associated with this firmware failure.
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; 06948538365892
Affected Firmware Version: G3-2.00.76
Affected Serial Numbers: https://en.bmc-medical.com/rc-adh.html
Users of the Luna G3 APAP (Model LG3600) who have the device can check their firmware version by:
- Obtain the device SN (please locate the SN from the label on the rear of the device as shown in the figure below) → Access the inquiry webpage (https://en.bmc-medical.com/rc-adh.html) → Enter the SN (input the obtained SN in the “Serial Number(SN)” box at the top of the webpage) → Click “Check My Device” to perform the query → Obtain the firmware version of the device
- Consulting their physician and Durable Medical Equipment (DME) provider to confirm if their Luna G3 APAP (LG3600, firmware version is safe to use.
- Alternately, customer should contact React Health (RH), the U.S. Importer for BMC, via email at: 3B-Recall@reacthealth.com for replacement of the uncorrected Luna G3 APAP (LG3600) device, firmware version: G3-2.00.76 with a new device for the prescribed therapy.
Affected devices operating with version G3-2.00-76 should be discontinued immediately until a replacement device is provided.
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.
Adverse reactions or quality problems experienced with the use of this product 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.
