Class I Recall Issued for BMC Medical's Luna G3 APAP Devices Due to Firmware Defect

The FDA announced a Class I recall for BMC Medical Co., Ltd.'s Luna G3 APAP (Model LG3600) devices with firmware version G3-2.00.76. A firmware defect could cause the device to display an 'Error' message and automatically shut down under specific operating conditions, leading to a failure to deliver therapy. This defect could result in serious adverse health consequences.