BMC Medical Co., Ltd.: BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Is my product affected?

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

• UPC 06948538363331
• UPC 06948538365892

Check against the official notice below — it lists the full affected range.

What happened

BMC Medical Co., Ltd. is recalling 20,160 units of the BMC/REACTHEALTH Luna G3 APAP device due to retroactive reporting for rework conducted in 2024 at the 3B/React Health warehouse. The recalled devices were distributed to Florida and have specific UDI codes (06948538363331 and 06948538365892), software version G3-2.00.76, and numerous serial numbers beginning with A3124918 or A3124919.

The record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Details from the source

Reason for recall: Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse Distribution: US distribution to: FL OUS: None Quantity: 20,160 units Lot/code info: UDI: 06948538363331; 06948538365892 Software Version: G3-2.00.76 Serial Numbers: A3124919140 A3124919145 A3124919181 A3124918105 A3124919105 A3124919148 A3124919131 A3124919151 A3124919130 A3124919147 A3124919153 A3124919126 A3124919149 A3124919144 A3124918225 A3124918400 A3124918379 A3124918407 A3124918228 A3124918390 A3124918398 A3124918268 A3124918260 A3124918341 A3124918259 A3124918285 A3124918251 A3124918464 A3124918255 A3124918257 A3124918261 A3124918172 A3124918267 A3124918266 A3124918280 A3124918212 A3124918269 A3124918382 A3124918271 A3124918130 A3124918246 A3124918525 A3124918282 A3124918528 A3124918294 A3124918362 A3124918529 A3124918358 A3124918374 A3124918516 A3124918364 A3124918509 A3124918511 A3124918366 A3124918385 A3124918372 A3124918376 A3124918263 A3124918512 A3124918380 A3124918287 A3124918085 A3124918300 A3124918297 A3124917180 A3124919172 A3124919058 A3124919054 A3124919116 A3124919057 A3124919189 A3124919112 A3124919115 A3124918327 A3124919100 A3124918197 A3124919120 A3124919191 A3124919186 A3124919118 A3124918115 A3124918317 A3124918429 A3124919137 A3124918153 A3124918207 A3124918069 A3124918323 A3124918023 A3124918136 A3124918070 A3124918081 A3124918134 A3124918051 A3124918114 A3124918283 A3124917222 A3124918182 A3124918030 A3124917146 A3124918037 A3124918180 A3124918185 A3124918169 A3124918042 A3124918183 A3124918056 A3124918166 A3124918038 A3124918163 A3124918448 A3124917327 A3124918160 A3124918444 A3124918124 A3124918441 A3124918107 A3124918256 A31

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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