3B Medical Luna G3 BPAP System recalled for incorrect pressure data
3B Medical is recalling Luna G3 BPAP Systems, a bi-level positive airway pressure device used to treat adult obstructive sleep apnea. When Targeted VT is enabled, the device records and transmits the configured IPAP value instead of the actual inspiratory pressure it delivers.
From the FDA notice · Read the official notice ↗ · All 3B Medical recalls
What to do
- Contact your sleep care team and 3B Medical before changing how you use the device, since it treats a medical condition.
- Check whether your device is model LG3800-30VT and whether its serial number is in the notice's list.
- The notice doesn't say how to get a repair or replacement; ask 3B Medical or your equipment supplier.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Luna G3 BPAP System Model/Catalog Number: LG3800-30VT Product Description: The Luna G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA).
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
Details
- Units affected
- 12672
- Illnesses reported
- None reported
- Manufactured in
- 5475 Rings Rd Ste 550, Dublin, Ohio, United States
- Classification
- Class I
- Recall number
- Z-0409-2027
In the FDA's words
- Description
- Luna G3 BPAP System Model/Catalog Number: LG3800-30VT Product Description: The Luna G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The configured IPAP value is recorded and transmitted instead of the actual delivered inspiratory pressure when Targeted VT is enabled. UDI-DI 06948538365731 Serial Numbers B3C22A17170 B3C22A17211 B3C22A17447 B3C22A18075 B3C22A18272 B3C22A18279 B3C22A18280 B3C22A18283 B3C22A18284 B3C22A18289 B3C22A18290 B3C22A18291 B3C22A18292 B3C22A18294 B3C22A18295 B3C22A18298 B3C22A18299 B3C22A18301 B3C22A18365 B3C22A18374 B3C22A18380 B3C22A18395 B3C22A18398 B3C22A18408 B3C22A18410 B3C22A18412 B3C22A18416 B3C22A18417 B3C22A18418 B3C22A18419 B3C22A18421 B3C22A18423 B3C22A18426 B3C22A18428 B3C22A18457 B3C22A20163 B3C22A21007 B3C22A21012 B3C22A21014 B3C22A21019 B3C22A21020 B3C22A21026 B3C22A21031 B3C22A21034 B3C22A21037 B3C22A21038 B3C22A21040 B3C22A21042 B3C22A21045 B3C22A21046 B3C22A21048 B3C22A21051 B3C22A21053 B3C22A21055 B3C22A21056 B3C22A21062 B3C22A21063 B3C22A21067 B3C22A21069 B3C22A21070 B3C22A21074 B3C22A21075 B3C22A21078 B3C22A21079 B3C22A21082 B3C22A21083 B3C22A21084 B3C22A21086 B3C22A21087 B3C22A21088 B3C22A21089 B3C22A21090 B3C22A21091 B3C22A21093 B3C22A21094 B3C22A21096 B3C22A21097 B3C22A21098 B3C22A21099 B3C22A21100 B3C22A21101 B3C22A21102 B3C22A21103 B3C22A21104 B3C22A21105 B3C22A21106 B3C22A21107 B3C22A21108 B3C22A21109 B3C22A21111 B3C22A21112 B3C22A21113 B3C22A21114 B3C22A21115 B3C22A21116 B3C22A21117 B3C22A21118 B3C22A21119 B3C22A21120 B3C22A21121 B3C22A21122 B3C22A21123 B3C22A21125 B3C22A21126 B3C22A21128 B3C22A21129 B3C22A21130 B3C22A21131 B3C22A21132 B3C22A21133 B3C22A21136 B3C22A21139 B3C22A21140 B3C22A21144 B3C22A21145 B3C22A21148 B3C22A21149 B3C22A21150 B3C22A21151 B3C22A21152 B3C22A21164 B3C22A21190 B3C22A21203 B3C22A21204 B3C22A21205 B3C22A21206 B3C22A21212 B3C22A21214 B3C22A21215 B3C22A21216 B3C22A21220 B3C22A21222 B3C22A21223 B3C22A21226 B3C22A21229 B3C22A21232 B3C22A21238 B3C22A21239 B3C22A21241 B3C22A21242 B3C22A21245 B3C22A21246 B3C22A21255 B3C22A21256 B3C22A21257 B3C22A21258 B3C22A21261 B3C22A21263 B3C22A21268 B3C22A21270 B3C22A21272 B3C22A21273 B3C22A21277 B3C22A21279 B3C22A21280 B3C22A21281 B3C22A21282 B3C22A21283 B3C22A21284 B3C22A21288 B3C22A21289 B3C22A21290 B3C22A21291 B3C22A21295 B3C22A21297 B3C22A21300 B3C22A21301 B3C22A21302 B3C22A21308 B3C22A21310 B3C22A21311 B3C22A21313 B3C22A21318 B3C22A21319 B3C22A21320 B3C22A21321 B3C22A21326 B3C22A21327 B3C22A21328 B3C22A21329 B3C22A21336 B3C22A21337 B3C22A21338 B3C22A21339 B3C22A21341 B3C22A21342 B3C22A21345 B3C22A21346 B3C22A21347 B3C22A21349 B3C22A21352 B3C22A21354 B3C22A21359 B3C22A21360 B3C22A21361 B3C22A21362 B3C22A21366 B3C22A21367 B3C22A21370 B3C22A21373 B3C22A21374 B3C22A21375 B3C22A21377 B3C22A21384 B3C22A21385 B3C22A21386 B3C22A21387 B3C22A21389 B3C22A21390 B3C22A21391 B3C22A21394 B3C22A21395 B3C22A21396 B3C22A21397 B3C22A21398 B3C22A21399 B3C22A21402 B3C22A21403 B3C22A21404 B3C22A21405 B3C22A21406 B3C22A21408 B3C22A21409 B3C22A21410 B3C22A21414 B3C22A21415 B3C22A21417 B3C22A21419 B3C22A21422 B3C22A21423 B3C22A21427 B3C22A21428 B3C22A21429 B3C22A22041 B3C22A22086 B3C22A22092 B3C22A22095 B3C22A22109 B3C22A22141 B3C22A22155 B3C22A22159 B3C22A22161 B3C22A22163 B3C22A22164 B3C22A22166 B3C22A22169 B3C22A22171 B3C22A22174 B3C22A22177 B3C22A22179 B3C22A22182 B3C22A22183 B3C22A22186 B3C22A22187 B3C22A22188 B3C22A22190 B3C22A22192 B3C22A22194 B3C22A22195 B3C22A23002 B3C22A23003 B3C22A23004 B3C22A23005 B3C22A23006 B3C22A23010 B3C22A23011 B3C22A23013 B3C22A23014 B3C22A23015 B3C22A23017 B3C22A23018 B3C22A23019 B3C22A23021 B3C22A23022 B3C22A23024 B3C22A23025 B3C22A23028 B3C22A23029 B3C22A23030 B3C22A23031 B3C22A23033 B3C22A23034 B3C22A23035 B3C22A23037 B3C22A23038 B3C22A23039 B3C22A23042 B3C22A23044 B3C22A23046 B3C22A23049 B3C22A23050 B3C22A23052 B3C22A23053 B3C22A23057 B3C22A23060 B3C22A23062 B3C22A23063 B3C22A23074 B3C22A23082 B3C22A23084 B3C22A23088 B3C22A23097 B3C22A23098 B3C22A23099 B3C22A23101 B3C22A23103 B3C22A23104 B3C22A23107 B3C22A23110 B3C22A23112 B3C22A23115 B3C22A23124 B3C22A23126 B3C22A23129 B3C22A23131 B3C22A23132 B3C22A23133 B3C22A23134 B3C22A23136 B3C22A23137 B3C22A23138 B3C22A23139 B3C22A23141 B3C22A23145 B3C22A23146 B3C22A23147 B3C22A23148 B3C22A23153 B3C22A23154 B3C22A23155 B3C22A23158 B3C22A23160 B3C22A23161 B3C22A23163 B3C22A23166 B3C22A23167 B3C22A23168 B3C22A23172 B3C22A23174 B3C22A23175 B3C22A23176 B3C22A23177 B3C22A23178 B3C22A23179 B3C22A23181 B3C22A23182 B3C22A23183 B3C22A23186 B3C22A23187 B3C22A23188 B3C22A23189 B3C22A23190 B3C22A23191 B3C22A23192 B3C22A23194 B3C22A23195 B3C22A23196 B3C22A23197 B3C22A23198 B3C22A23199 B3C22A23200 B3C22A23201 B3C22A23202 B3C22A23204 B3C22A23206 B3C22A23208 B3C22A23210 B3C22A23211 B3C22A23212 B3C22A23214 B3C22A23216 B3C22A23217 B3C22A23219 B3C22A23221 B3C22A23228 B3C22A23231 B3C22A23232 B3C22A23233 B3C22A23235 B3C22A23238 B3C22A23243 B3C22A23245 B3C22A23246
- Hazard
- The configured IPAP value is recorded and transmitted instead of the actual delivered inspiratory pressure when Targeted VT is enabled.