Medical Device Safety

FDA posts Class I recall for Luna G3 APAP devices over shutdown risk

A firmware defect can shut down certain Luna G3 APAP machines during an unusual combination of operating conditions. The model, firmware version and serial number—not the brand name alone—determine the next step.

September 8, 2026 · 7 min read

Man checking the serial-number label on a generic home sleep-therapy machine while reading a recall notice

The public notice reaches a recall that began behind the scenes

The Food and Drug Administration posted a company announcement September 8 for a Class I recall involving 20,160 Luna G3 APAP machines, model LG3600, distributed across the United States. BMC Medical had reported the recall to FDA on July 15 after a warehouse firmware correction that ran from October through December 2024. According to the FDA notice, that corrective action had not been reported to customers. FDA classified the event as Class I on August 19, and the company issued the public announcement September 7. The timing matters because a machine that has worked normally for months can still require a serial-number and firmware check.

The defect can interrupt prescribed therapy

BMC says firmware version G3-2.00.76 contains debug code that can trigger when three conditions occur at the same time: high pressure, a high respiratory rate and high peak flow. The display can show an “Error” message and the machine can shut down, stopping therapy. FDA says the defect could cause unintended serious adverse health consequences. Its notice says BMC had received no complaints or serious adverse reports associated with this firmware failure. BMC’s longer notification separately records 210 complaints for distributed devices through July 31, but says none were related to this defect and none were reportable events. Those statements do not cancel the recall, and the Class I label describes FDA’s assessment of the potential hazard rather than proof that every listed machine has failed.

Most machines in the recall scope were corrected, but 196 still needed resolution

The manufacturer’s recall notification separates the 20,160 devices into three groups: 19,964 were confirmed on corrected firmware G3-2.00.77; 40 were confirmed in the field with affected firmware G3-2.00.76; and 156 had not connected to the cloud, so their firmware status remained pending. FDA summarizes the unresolved group as potentially up to 196 units that did not receive the upgrade. The devices were manufactured from September 11 through October 18, 2024 and distributed nationwide between October 29, 2024 and July 6, 2026. There is no published California-specific unit or incident count, so this article does not imply a local cluster.

Check the model and serial number before acting

The affected product is the Luna G3 APAP, model LG3600, with UDI numbers 06948538363331 or 06948538365892. Find the serial number on the label at the rear of the machine, then use BMC’s official recall checker. The checker accepts the number with or without the “SN” prefix. A result showing G3-2.00.77 means the device is corrected and the manufacturer says no additional action is required. A result showing G3-2.00.76 means the affected firmware remains. A “pending” result means the checker cannot confirm the firmware; it is not the same as a cleared result. Photograph the label and save the checker result so the device, DME provider and replacement request stay matched.

An affected result calls for a replacement—not a home repair

FDA says a device operating with firmware G3-2.00.76 should be discontinued immediately until a replacement is provided. The agency directs users to consult the clinician who prescribed the therapy and their durable medical equipment provider, and to contact U.S. importer React Health at 3B-Recall@reacthealth.com for replacement of an uncorrected machine. BMC’s checker tells users with a pending result to contact the same clinical and equipment channels because the version is unconfirmed. Do not open the case, install firmware from an unofficial download, discard the device or substitute a different pressure setting on your own. Prescription settings and an alternative device need to be handled by the appropriate clinician and equipment provider.

Use the official contacts and keep a short paper trail

React Health lists 863-226-6285 and 3B-Recall@reacthealth.com for recall questions, Monday through Friday from 8 a.m. to 5 p.m. Eastern time. BMC also lists bmc-recall@bmc-medical.com. Record the date, the serial number, the checker result, the person or organization contacted and the replacement or return instructions received. If a seller, text message or social account asks for payment, a bank login or a one-time code to process the recall, stop and return to the contact information in the FDA notice. The announced remedy is a replacement for an uncorrected device; the official notice does not instruct users to pay a recall fee.

Report a device problem, and treat urgent breathing trouble as urgent

Patients and health professionals can report a suspected malfunction, therapy interruption or other product-quality problem through FDA MedWatch. A report does not determine whether the firmware caused an event, but it gives regulators details they can evaluate. Call 911 for severe trouble breathing or another life-threatening emergency. A NOCTI article, directory listing, massage appointment or online device forum cannot replace emergency care, a sleep-medicine clinician or a durable medical equipment provider.

What is known—and what still requires a device-specific answer

Confirmed facts include the model, the affected and corrected firmware versions, the nationwide distribution period, the 20,160-unit recall scope and the 196 machines that were affected or still pending when the notice was prepared. FDA and BMC provide the serial-number checker and replacement contacts. They do not publish a consumer-by-consumer list, a California breakdown or evidence that every LG3600 is unsafe. The safest concise question is therefore not “Do I own a Luna machine?” but “Does my LG3600 serial number show G3-2.00.76, G3-2.00.77 or pending?” This report is educational and does not change a prescription or provide individual medical advice.

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