The agency cited unapproved modifications to the an auto-CPAP system imported into the United States and a failure to report a firmware correction for unexpected shutdowns.
Key takeaways:
- The FDA issued a warning letter to BMC Medical regarding G3X APAP and Luna G3 APAP devices imported to the United States by React Health.
- The agency states the G3X APAP requires a new 510(k) clearance due to significant design, material, and firmware modifications from the previously cleared Luna system.
- The manufacturer was also cited for failing to report a firmware update initiated to fix an unexpected shutdown issue in Luna G3 APAP devices.
- React Health and BMC Medical did not respond to requests for comment.
The US Food and Drug Administration (FDA) issued a warning letter to Beijing-based BMC Medical Co Ltd citing unapproved device modifications and reporting violations related to CPAP and auto-adjusting positive airway pressure (APAP) devices imported to the United States by 3B Medical Inc, which does business as React Health Inc.
Following an inspection of React Health’s Dublin, Ohio, facility in December 2025, the FDA determined BMC Medical is the specification developer and 510(k) owner of the devices in question.
According to the May 20 warning letter, BMC Medical’s G3X APAP devices are considered adulterated and misbranded because the company introduced them into interstate commerce without submitting a new premarket notification, or 510(k), to the FDA. The agency states that BMC Medical made significant design and material modifications to the Luna CPAP and Auto CPAP System, which was originally granted clearance in 2016, effectively creating the new G3X APAP model.
The FDA letter details that firmware and software were updated with new recognition features—including flow limitation, respiratory effort-related arousals, and periodic breathing—to distinguish between central and obstructive hypopnea events. The agency notes these algorithm changes affect the accuracy of event classification and the data available to clinicians.
Additionally, the FDA found that the sound abatement system of the cleared Luna APAP was modified, representing a material change to the gas pathway that raises biocompatibility concerns. The printed circuit board assembly was also updated with a new chip compatible with the new algorithms. The FDA states that collectively, these modifications in design, materials, and software could significantly affect the safety and effectiveness of the device.
The warning letter also cites BMC Medical for failing to report a medical device correction to the FDA within the required 10 working days. The agency found that Luna G3 APAP devices utilizing firmware version G3-2.00.76 could unexpectedly shut down during use, causing a loss of therapy for patients with obstructive sleep apnea. BMC Medical initiated a firmware update to version G3-2.00.77 to remedy the issue, which the FDA classifies as a medical device correction to reduce a health risk. As of May 19, 2026, the FDA had not received a report of this correction.
The FDA requested that BMC Medical cease any activities resulting in the misbranding or adulteration of the devices and notify the agency in writing within 15 business days of the specific steps taken to address the violations.
React Health and BMC Medical did not respond to requests for comment.
