The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.
The US Food and Drug Administration has classified a recall of certain BMC Medical Luna G3 automated positive airway pressure (APAP) devices as Class I after a firmware defect was found that can cause the devices to shut down and stop delivering therapy.
The recall involves Luna G3 APAP Model LG3600 devices with firmware version G3-2.00.76. BMC Medical initially updated 20,160 affected devices at US importer React Health’s warehouse in 2024 but later determined that up to 196 units may not have received the update and could still contain the defective firmware, according to the company announcement posted by the FDA.
Operating Conditions and Potential Hazards
Under specific operating conditions, the firmware defect can cause the device to shut down unexpectedly. According to BMC Medical, 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.
The company stated that the defect could result in unintended serious adverse health consequences. However, BMC Medical has received no complaints or reports of serious adverse events associated with the firmware failure to date, according to the announcement.
Scope of the Corrective Action
BMC Medical conducted a firmware upgrade of 20,160 affected devices to version G3-2.00.77 at React Health’s warehouse between October and December 2024. On July 15, 2026, the company retrospectively reported the recall of those devices to the FDA. The corrective action had not been reported to customers, according to the announcement.
The FDA classified the retrospective recall as Class I on Aug 19, 2026.
After reporting the recall, BMC Medical discovered that up to 196 units may not have received the intended upgrade and could still contain firmware version G3-2.00.76.
The affected devices were manufactured between September 11, 2024, and October 18, 2024, and distributed by BMC Medical to React Health between September 20, 2024, and October 19, 2024. The devices were distributed nationwide between October 29, 2024, and July 6, 2026, according to the manufacturer.
Guidance for Affected Devices
BMC Medical advises that any Luna G3 APAP Model LG3600 operating with firmware version G3-2.00.76 should be discontinued immediately until a replacement device is provided.
The firmware version can be checked by locating the device serial number on the rear label and entering it into BMC Medical’s online verification tool. Customers may also consult their physician and durable medical equipment provider or contact React Health to arrange for an uncorrected device to be replaced.
