BMC Medical Co., Ltd. has recalled its Luna G3 APAP device (model LG3600) due to a firmware defect that can cause the machine to display an error message and shut down automatically, cutting off therapy delivery, the U.S. Food and Drug Administration announced. The FDA has classified the action as a Class I recall, its most serious designation, reserved for situations where continued use of the product could cause serious injury or death.
According to the FDA, the defect affects units running firmware version G3-2.00.76. When the device operates under a specific combination of conditions — high pressure, high respiratory rate, and high peak flow occurring simultaneously — it triggers an “Error” message followed by an automatic shutdown, resulting in a failure to deliver therapy.
The affected devices were manufactured between September 11 and October 18, 2024, and distributed between October 29, 2024, and July 6, 2026. BMC has since issued firmware upgrades to 20,160 devices, but the company estimates that up to 196 units may still be running the unpatched, defective version.
BMC reported the issue to the FDA on July 15, 2026, and the agency finalized the Class I classification on August 19, 2026 (FDA Recall Number Z-2979-2026). As of the recall notice, BMC said it has not received any complaints or reports of serious adverse events tied to the firmware failure.
What Patients and Providers Should Do
The FDA and BMC are advising users of the Luna G3 APAP to check their device’s firmware version using their unit’s serial number via BMC’s website; contact their physician or durable medical equipment (DME) provider with any questions about continued use; and reach out to React Health, the device’s U.S. distributor, to arrange for a replacement unit if their device is running the affected firmware version.
Patients experiencing therapy interruptions or error messages on their device should discontinue use and contact their care provider or DME supplier immediately.
Device Identification
Affected devices can be identified by the following Unique Device Identifiers (UDIs): 06948538363331 and 06948538365892.
Sleep medicine professionals and patients seeking additional information can consult the FDA’s MedWatch program to report any adverse events related to this device.
Written by SleepWorld Magazine staff
