Class I Recall: BMC Luna G3 APAP Devices Can Shut Down Because of a Firmware Defect
BMC Medical has reported a Class I recall of Luna G3 APAP sleep apnoea devices (model LG3600) running firmware version G3-2.00.76. Under a combination of high pressure, high breathing rate and high peak flow, the device shows an error and shuts down, which stops therapy.
BMC updated most of the 20,160 affected US devices to firmware G3-2.00.77 in late 2024, but did not tell customers. It later found that up to 196 units may never have been updated. BMC has received no complaints or serious adverse event reports linked to the fault.
Key points
- Affected device: Luna G3 APAP, model LG3600, with firmware G3-2.00.76.
- Fault: an error message followed by automatic shutdown under high pressure, respiratory rate and peak flow.
- Up to 196 US units may still have the faulty firmware.
- Users can check their device's serial number on BMC's recall webpage.
What it means for you
Patients using a BMC Luna G3 APAP should check its firmware version with their supplier. A device that shuts down unexpectedly during sleep means the patient is getting no therapy.
BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.