A firmware bug can shut off 20,160 recalled sleep apnea machines mid-therapy

The Food and Drug Administration has classified a firmware defect in 20,160 BMC Medical sleep apnea machines as a Class 1 recall, its most serious category, after finding the devices can display an error message and shut themselves off in the middle of a therapy session. The affected machines are Luna G3 APAP units, model LG3600, running firmware version G3-2.00.76.

Roughly 196 of those 20,160 devices may still be running the flawed firmware today, according to the manufacturer’s own estimate. BMC Medical has not reported any injuries or deaths tied to the defect.

A firmware defect can trigger a mid-therapy shutdown

The problem shows up only under a specific combination of conditions: when a Luna G3 APAP is operating simultaneously under high pressure, high respiratory rate and high peak flow, the firmware triggers an on-screen error message followed by an automatic shutdown, according to the FDA’s recall notice. “If an affected APAP device operates simultaneously under high pressure, high respiratory rate, and high peak flow, an error message appears on the display, followed by an automatic shutdown that stops delivery of positive airway pressure therapy,” BMC Medical said in its own account of the defect, carried by 24×7 Magazine.

An APAP machine automatically adjusts air pressure throughout the night to keep a sleep apnea patient’s airway open, so a mid-session shutdown means therapy simply stops until the device is manually restarted — a gap that could last through the rest of a sleep cycle if the user does not wake up to notice it.

20,160 machines were already updated; up to 196 might not be

BMC Medical, based in Beijing, upgraded firmware on 20,160 Luna G3 APAP units at its U.S. importer’s warehouse between October and December 2024, well before the recall was formally reported. The company later determined that as many as 196 of those units may not have actually received the fix, leaving them on the defective G3-2.00.76 firmware without anyone realizing it, according to Respiratory Therapy‘s account of the recall.

The devices themselves were distributed nationwide between late October 2024 and July 6, 2026, meaning some units now subject to the recall have been in patients’ homes for close to two years. The FDA notice lists two specific unique device identifiers tied to the affected lot, 06948538363331 and 06948538365892, the kind of barcode-level detail regulators use to distinguish a recalled unit from other Luna G3 models that never carried the defective firmware.

BMC Medical didn’t report the defect for a year and a half

BMC Medical completed its firmware upgrade of the affected devices by the end of 2024 but did not formally report the recall to the FDA until July 15, 2026 — a gap of roughly a year and a half between the company’s own corrective action and the government learning about it. The FDA then classified the action as Class 1 on Aug. 19, 2026 and published the notice to its public recall database on Sept. 8, 2026, under recall number Z-2979-2026.

A Class 1 recall is the FDA’s designation for “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the agency’s own recall classification definitions. That is a sharper label than a Class 2 recall, reserved for products where serious harm is only a remote possibility, or a Class 3 recall, where harm is not expected at all.

Patients are told to check a serial number before their next night’s sleep

BMC Medical is directing owners to check their own device rather than waiting for a company mailing. Patients can enter their unit’s serial number, found on the label on the back of the machine, into BMC’s online device-lookup tool to see whether it is running the affected G3-2.00.76 firmware.

Anyone whose device comes back positive is instructed to stop using it immediately and contact React Health, the U.S. distributor, at 863-226-6285 or by emailing its recall line, Monday through Friday from 8 a.m. to 5 p.m. Eastern, to arrange a replacement rather than attempt a fix at home. “The company has received no complaints or reports of serious adverse events associated with the firmware failure to date,” BMC Medical said, though the FDA’s Class 1 designation reflects the potential severity of an untreated shutdown rather than any confirmed harm so far.

React Health, not BMC Medical, is the point of contact for the actual replacement process, since it distributed the devices to patients and providers after they left BMC’s Beijing manufacturing operation. That split between manufacturer and distributor is typical for imported medical devices and is part of why the recall names both companies rather than one.

For a device meant to run unattended through the night, the instruction is unusually direct: check the serial number now, rather than wait to see whether an error message shows up first.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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