FDA Classifies Luna G3 Recall After Firmware Could Stop Therapy
The FDA has classified as Class I a nationwide recall involving BMC Medical’s Luna G3 APAP Model LG3600 breathing machines after firmware on some devices was found to potentially trigger an error and automatic shutdown under specific operating conditions.
The affected firmware version is G3-2.00.76. If the device is operating simultaneously under high pressure, a high respiratory rate and high peak flow, it may display an “Error” message and shut down, interrupting positive-airway-pressure therapy.
People who use a Luna G3 APAP Model LG3600 should check the machine’s serial number and firmware version. Anyone with a device confirmed to have firmware G3-2.00.76 should discontinue its use and contact the prescribing care team, durable medical equipment provider and React Health about a replacement. Patients should not change pressure settings or attempt to repair or update the machine themselves.
Up to 196 devices may still have the affected firmware
BMC reported that 20,160 Luna G3 APAP devices were distributed in the United States. That is the broader population covered by the corrective action, not the number known to remain affected.
According to the FDA-posted company announcement, BMC upgraded those devices from firmware G3-2.00.76 to G3-2.00.77 at the U.S. importer’s warehouse from October through December 2024. After the company reported the retrospective recall, it determined that potentially up to 196 units may not have received the upgrade and may still contain G3-2.00.76.
The devices were manufactured from Sept. 11 through Oct. 18, 2024, and distributed nationwide from Oct. 29, 2024, through July 6, 2026. React Health is identified as BMC’s U.S. importer.
BMC said it had received no complaints or serious adverse reports associated with the firmware failure as of the recall notice. The company announcement says the defect could result in unintended serious adverse health consequences, but it does not report patient injuries or deaths.
Why the FDA record calls it a retrospective recall
The corrective work occurred before BMC reported the action to the FDA. The company reported the recall on July 15, 2026. The FDA recall database lists the action as open and classified, with recall number Z-2979-2026, and shows an Aug. 19, 2026, posting date.
BMC’s announcement is dated Sept. 7, and the FDA posted the company announcement on Sept. 8. FDA’s recall page identifies the material as a company announcement and says the agency posts such notices as a public service.
That sequence is why the action is described as retrospective: the firmware upgrade work took place in late 2024, while the formal report to the FDA came on July 15, 2026.
How to check a Luna G3 APAP device
Owners should locate the serial number on the label at the rear of the device. They can then use the serial-number inquiry page identified in the FDA notice, enter the number in the “Serial Number (SN)” box and select “Check My Device” to obtain the firmware information.
Patients can also ask their physician or durable medical equipment provider to confirm whether the device is safe to use. Firmware G3-2.00.76 is the version identified as affected; G3-2.00.77 is the upgrade referenced in the recall record.
What affected users should do
The FDA notice says devices operating with firmware G3-2.00.76 should be discontinued immediately until a replacement is provided. Users should contact their prescribing care team and React Health, the U.S. importer, about replacement equipment. React Health lists a recall phone number of 863-226-6285 and the email address 3B-Recall@reacthealth.com.
Because positive-airway-pressure therapy may be medically necessary, patients should promptly ask a physician or qualified provider about a replacement or safe interim plan rather than stopping treatment without medical guidance. The Class I designation is the FDA’s recall classification; it does not mean that all 20,160 devices remain defective or that a shutdown will occur during ordinary use.
Sources
- FDA recall announcement: BMC Medical Luna G3 APAP Model LG3600
- FDA recall database: Class 1 Device Recall BMC/REACTHEALTH Luna G3 APAP
- Respiratory Therapy: Luna G3 APAP Recalled Due to Firmware Defect
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