Luna G3 APAP (Model LG3600)
Product details
- Luna G3 APAP (Model LG3600)
Company announcement
BMC Medical Co., Ltd. is recalling 20,160 Luna G3 APAP (Model LG3600) devices distributed nationwide in the United States.
The recall is due to a firmware defect (version G3-2.00.76) that can cause the device to display an "Error" message and shut down, failing to deliver therapy under specific operating conditions (high pressure, high respiratory rate, and high peak flow).
Approximately 196 units may still contain the affected firmware despite an attempted upgrade.
Impacted products were distributed between October 29, 2024, and July 6, 2026.
No complaints or serious adverse reports, including deaths or injuries, have been associated with this firmware failure to date.
Risk:
The firmware defect could result in unintended serious adverse health consequences by causing the device to fail to deliver therapy.
Impacted states: Nationwide
Products:
- Luna G3 APAP
Contact
For more information, call 863-226-6285 or email (RH) 3B-Recall@reacthealth.com, (BMC) bmc-recall@bmc-medical.com.
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