August 26, 2026
Recall Number: Z-2979-2026
Dear Valued Customer: React Health （3B Medical, Inc. d/b/a React Health）
BMC Medical Co., Ltd (hereinafter referred to as BMC) is retroactively notifying consignees of a voluntary correction conducted in 2024 for certain Luna G3 APAP devices manufactured by BMC. This issue was discovered during software system testing.
BMC has acknowledged that firmware upgrades were unsuccessful on certain affected products. Accordingly, this letter serves as the second recall notification your company has received for this recall activity.
Affected Product Details：
Product: Luna G3 APAP
Model: LG3600
Part No.: LG3600, LG36002
PI No.: PI-3BM-H2459, PI-3BM-H2460, PI-3BM-H2464, PI-3BM-H2465, PI-3BM-H2466, PI-3BM-H2469, PI-3BM-H2471
UDI-DI: 06948538363331, 06948538365892
UDI: Complete UDI information can be found in Attachment 1 to this notification.
Total Quantity: 20,160 units
Configuration Profile: G3 A20-31.cfg
Original firmware: G3-2.00.76
Corrected firmware: G3-2.00.77
Confirmed Current Firmware: Please refer to Attachment 2
The G3-2.00.76 firmware installed on the LG3600 device contained debug code. When the device operated under a combination of 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.
Current Status
BMC has become aware that certain Luna G3 APAP devices (Model LG3600) within the above-referenced recall scope did not complete successful firmware upgrade during the on-site firmware upgrade activities performed at the U.S. warehouse from October 2024 to December 2024, and some of these LG3600 units were subsequently released to the field. Details are set forth below:
l Firmware Version G3-2.00.77 (Confirmed): 19,964 units
l Firmware Version G3-2.00.76 (Confirmed): 40 units, in the field.
l Firmware Version Pending: 156 units, these devices have not connected to the cloud platform, so their firmware-version status cannot be determined.
Health Risk
The aforementioned specific Luna G3 APAP devices (Model LG3600), if still running firmware version G32.00.76, may display an “Error” message and automatically shut down under the occurance of all three simultaneous extreme conditions — high pressure, high respiratory rate, and high peak flow — resulting in therapy interruption.
Within the intended OSA patient population, shut down of the LG3600 during use will neither exacerbate Obstructive Sleep Apnea (OSA) nor pose a risk of asphyxiation. Furthermore, the combination of the three abovenoted operating conditions is not a clinically expected scenario for the Luna G3 APAP (Model LG3600), and the probability of occurrence is extremely low.
Since the affected devices were released in December 2024, BMC has received a total of 210 complaints as of July 31, 2026, with no reportable events identified. Furthermore, the aforementioned complaints are unrelated to the defect addressed by the voluntary correction action described in this notification.
The Luna® G3 APAP is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of Obstructive Sleep Apnea (OSA). The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient re-use in the home environment or for multi-patient re-use in the hospital/institutional environment. It is to be used on adult patients > 66 lbs/30 kg for whom CPAP therapy has been prescribed.
1. BMC requests React Health to complete the following items within seven business days from the date of confirming receipt of this notice:
(i) Carefully review and confirm full understanding of all contents in this recall notice and the associated implementation requirements.
(ii) Complete the Recall Response Form attached to this notice.
(iii) Send the signed the Recall Response Form to BMC via email.
2. Confirm the Current Distribution Status of Recalled Products.
The scope of confirmation shall include, at a minimum:
(i) Devices already distributed to medical institutions, customers, or end users.
(ii) Inventory in React Health's U.S. warehouse.
(iii) Devices that have been returned to BMC.
(iv) A cross-reference mapping recalled product orders / serial numbers to their respective status aforementioned.
(v) Compile an Microsoft Excel file and provide it to BMC via email.
3. Delivery of Recall Notications
Upon receipt of BMC's recall notice, React Health shall issue recall notifications to all affected distributors within the United States as soon as practicable. The Customer Recall Letter in Appendix 3 may be used as a reference template for drafting the aforementioned notifications. Affected customers shall be notified of the following required actions:
(i) For the 19,964 devices confirmed to bear firmware version G3-2.00.77:
l Inform the affected distributors of the details of this recall and obtain their written acknowledgment letters.
l No additional actions are required.
(ii) For the 40 devices confirmed to bear firmware version G3-2.00.76 and the 156 devices with undetermined firmware versions:
l Inform the affected distributors of the details of this recall and obtain their written acknowledgment letters.
l Locate the devices and determine the distribution status of each device.
l Quarantine the affected devices; further distribution, transfer, or use is prohibited.
l Notify affected customers or users, verify the firmware version of each device, record any devices still running firmware version G3-2.00.76, and instruct that such devices shall be decommissioned.
l Contact React Health to coordinate replacement with alternative devices, and remove devices with firmware version G3-2.00.76 from the field and return them to a location designated by React Health.
4. Product Disposition
Scope of Products to be Destructed:
(i) Devices confirmed to be within the scope of this notice that are stored in React Health's warehouse and are non-distributable, non-conforming, or returned.
(ii) The aforementioned devices whose firmware upgrade was unsuccessful and that are still running firmware version G3-2.00.76.
React Health is responsible for developing a controlled destruction plan applicable to the aforementioned products requiring destruction, engaging a qualified destruction vendor, and implementing the destruction of the products. If the FDA requires supervision of the destruction process, React Health shall cooperate with the FDA in its implementation.
BMC is responsible for communicating the destruction plan with the FDA Recall Coordinator. BMC may only authorize React Health to proceed with product destruction after the plan has been approved by the FDA.
5. Recall Effectiveness Check
The recall effectiveness check will be conducted jointly by BMC and React Health, and will be evaluated by tracking the notification of downstream distributors within the United States and the completion status of corresponding activities.
React Health is responsible for implementing the tracking and evaluation in the United States; BMC is responsible for monitoring the execution of React Health's recall activities in the U.S. and the progress of the aforementioned tracking activities, and reporting to the FDA on a regular basis.
React Health shall perform the following effectiveness checks:
(i) Verify and document the current firmware version for products within the recall scope via React Health Connect:
l If the running firmware version is G3-2.00.77, issue recall notifications in accordance with clause 3(i) of this notice. Verification and documentation of version information shall serve as the effectiveness check method for these units.
l If the running firmware version remains G3-2.00.76, perform recall notification issuance and effectiveness checks in accordance with clauses 3(ii) and 5(iii) of this notice.
l If devices are not connected to React Health Connect such that the firmware version cannot be confirmed temporarily, perform recall notification issuance and effectiveness checks in accordance with clauses 3(ii) and 5(iv) of this notice.
(ii) Confirm that formal recall notifications have been issued to all relevant downstream distributors, obtain written acknowledgments of receipt from the distributors, and verify that the notifications have been delivered.
(iii) Track the disposition progress by affected distributors for the 40 distributed devices whose firmware remains at version G3-2.00.76：
Confirm that the affected devices have been decommissioned, removed from the field, and replaced with alternative devices.
(iv) Monitor the disposition progress for the 156 devices with uncertain firmware versions:
l Track distributors' follow-up with end users and the results of firmware verification;
l Record any devices identified as having firmware version G3-2.00.76;
l Confirm that devices with firmware version G3-2.00.76 have been decommissioned, moved from the field, and replaced with other devices.
(v) Periodically reconcile distribution records, serial number cross-references, and feedback data to identify any potentially overlooked affected devices.
(vi) Products within the recall scope requiring destruction:
Complete destruction after the destruction plan has been approved by BMC and the FDA, and retain destruction records. Where applicable, the FDA may require supervision of the destruction process.
(vii) Communicate recall progress with BMC monthly:
Distributor response records, progress of products pending return, list of devices with firmware version G3-2.00.76, and the destruction plan; conduct periodic sampling audits to assess the overall progress and effectiveness of the recall.
(viii) React Health shall complete the corresponding recall effectiveness assessment and form a report.
(ix) The recall shall be deemed effective when there is sufficient evidence that the required corrective measures have been completed for all reasonably traceable affected devices.
BMC shall perform the following effectiveness checks：
(i) Track the progress of this recall through monthly communications with React Health, conduct periodic sampling audits, and assess the overall progress and effectiveness of the recall.
(ii) Prepare recall progress reports and report recall updates to the FDA Recall Coordinator on a monthly basis.
(iii) When BMC and React Health have assessed that the recall is complete and a recall effectiveness assessment report has been issued, communicate with the FDA Recall Coordinator to determine whether this recall may be terminated.
Should you have any questions regarding this Recall, you may contact BMC via the email address below 24 hours a day, Monday through Sunday.
Email: bmc-recall@bmc-medical.com