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Luna G3 APAP Recall: FDA Warns Some LG3600 Devices May Still Have Faulty Firmware
Users of the Luna G3 APAP sleep-therapy device are being urged to check their machine after the FDA published details of a Class I recall involving firmware that can cause the device to shut down and stop delivering therapy under certain operating conditions.
YuToday Staff
· 1 min read · September 11, 2026
Key takeaways
- BMC Medical reported a recall involving Luna G3 APAP Model LG3600 devices fitted with firmware version G3-2.00.76.
- A shutdown could result in therapy no longer being delivered.
- The corrective action involved 20,160 devices distributed in the United States.
Why the Device Was Recalled
BMC Medical reported a recall involving Luna G3 APAP Model LG3600 devices fitted with firmware version G3-2.00.76. According to the FDA notice, the firmware defect can trigger an error followed by automatic shutdown when the device is operating under a combination of high pressure, high respiratory rate and high peak flow. A shutdown could result in therapy no longer being delivered.
How Many Devices Could Be Affected
The corrective action involved 20,160 devices distributed in the United States. BMC upgraded devices at its U.S. importer's warehouse to firmware G3-2.00.77, but later determined that potentially as many as 196 units may not have received the update. The FDA says the retrospective recall was classified as Class I. No complaints or serious adverse reports linked to the firmware failure had been reported in the FDA announcement.
How Owners Can Check Their Luna G3
People using a Luna G3 APAP LG3600 should locate the serial number on the rear label and use BMC's device-checking process to confirm the firmware version. The FDA notice says devices still running firmware G3-2.00.76 should be discontinued until a replacement is provided. Users should also contact their physician or durable medical equipment provider for guidance about their prescribed therapy.