FDA Drugs (New Approvals & NDA)Original article
BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect
RegulatoryLuna G3 APAPNegative
AI Analysis
Summary
BMC Medical Co., Ltd. retrospectively reported to the FDA a recall of 20,160 Luna G3 APAP devices distributed in the United States due to a firmware defect, which was not reported to customers.
Outcome Details
Firmware defect recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States. Corrective action was not reported to customers.
Importance:6/10
Sentiment:
-0.80
recallfirmware defectregulatory actiondevice safetyAPAPFDA
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Published by FDA Drugs (New Approvals & NDA) on September 8, 2026 3:41 PM