MEDICAL DEVICE RECALL — HEALTH & ACCESS

Check your Luna G3. One APAP firmware version can shut down mid-therapy.

FDA says a small group of Luna G3 APAP devices may still run firmware that can trigger an error and automatically shut down, interrupting prescribed sleep-apnea therapy. The check is exact: model LG3600 with firmware G3-2.00.76.

Start with the label on the back

Find the serial number on the rear label, then use BMC’s official serial-number checker ↗. The checker sorts devices into three groups: affected firmware G3-2.00.76, corrected firmware G3-2.00.77 or firmware status pending.

If the result is G3-2.00.77, BMC says the firmware is corrected and no additional recall action is required. If the status is pending, the company says the device has not connected to its cloud system, so the version cannot be confirmed; contact the prescriber, equipment provider or React Health rather than assuming it is safe.

What the defect can do

The company says firmware G3-2.00.76 contains code that can trigger an “Error” message and automatic shutdown when high pressure, a high respiratory rate and high peak flow occur at the same time. The shutdown stops the device from delivering therapy.

FDA classified the recall as Class I on August 19, the agency’s most serious recall category, and says the defect could cause serious adverse health consequences. The September 8 announcement also says BMC had received no complaints or serious adverse reports tied to this firmware failure.

BMC’s own notification says the three-condition combination is not clinically expected and describes its likelihood as extremely low. It also says a shutdown would not worsen obstructive sleep apnea or create an asphyxiation risk. Those company statements do not change FDA’s Class I classification or the public instruction to stop using a device confirmed on the affected firmware until replacement.

Most devices were corrected; some remain unresolved

The original correction covered 20,160 devices. BMC says 19,964 are confirmed to run corrected firmware, 40 are confirmed to remain on G3-2.00.76 and 156 have an unconfirmed version because they have not connected to the cloud platform. FDA describes as many as 196 units as potentially not upgraded.

The devices were distributed nationwide between October 29, 2024, and July 6, 2026. That makes the recall relevant to any Rockland resident with the exact model, but neither FDA nor BMC identifies a Rockland purchaser, equipment supplier or healthcare facility.

Do not guess about replacement therapy

FDA says an LG3600 confirmed to run G3-2.00.76 should be discontinued immediately until a replacement is provided. Because APAP is prescribed therapy, contact the prescribing clinician or durable medical equipment provider promptly for an individual plan rather than substituting settings, firmware or another device on your own.

React Health, the U.S. importer, is coordinating replacements. BMC’s serial checker tells users with affected firmware to stop use and quarantine the device; the FDA announcement lists 863-226-6285 and 3B-Recall@reacthealth.com for recall questions.

The useful move is a two-part check: confirm model LG3600, then run the rear serial number through the official checker. Corrected firmware G3-2.00.77 needs no recall action; affected G3-2.00.76 should be taken out of use while the prescriber, equipment provider or React Health arranges the next step.

Primary sources: FDA-posted BMC recall announcement ↗, FDA-published September 8, 2026; BMC affected-serial-number checker ↗; and BMC recall notification ↗. Checked September 8, 2026, at 1:49 p.m. EDT. The Rockland Edit has not confirmed a Rockland device, purchaser or adverse event and does not provide individualized medical advice.