FDA MedWatch Safety AlertsOriginal article
BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) Devices with Firmware G3-2.00.76 Configured with G3 A20-31.cfg
RegulatoryLuna G3 APAPNegative
AI Analysis
Summary
BMC Medical Co., Ltd. retrospectively reported a recall of 20,160 Luna G3 APAP devices (Model LG3600) to the FDA on July 15, 2026 due to a firmware defect. The recall was not reported to customers.
Outcome Details
Device recall due to firmware defect (Model LG3600 with Firmware G3-2.00.76)
Importance:4/10
Sentiment:
-0.80
device recallfirmware defectFDAsafety
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Published by FDA MedWatch Safety Alerts on September 8, 2026 4:00 AM