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U.S. Department of Health and Human Services

Class 1 Device Recall Luna G3 BPAP System

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 Class 1 Device Recall Luna G3 BPAP Systemsee related information
Date Initiated by FirmOctober 08, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0409-2027
Recall Event ID 100001
510(K)NumberK212263 
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
ProductLuna 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).
Code Information 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 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FEI Number 3009096682
Recalling Firm/
Manufacturer
3B Medical, Inc.
5475 Rings Rd Ste 550
Dublin OH 43017-7677
For Additional Information ContactGeorge Koos
1-863-2266285
Manufacturer Reason
for Recall
The configured IPAP value is recorded and transmitted instead of the actual delivered inspiratory pressure when Targeted VT is enabled.
FDA Determined
Cause 2
Device Design
ActionThe firm began notifying customers on October 9, 2026. Customers should immediately discontinue use of Targeted VT if enabled on affected devices. Affected devices should be removed from clinical service and segregated to prevent further use. Customers should use unaffected PAP devices for patient support. The product will be updated by the customer with a firmware correction provided by React Health to ensure conformance to product requirements. The firmware correction will be sent out upon receipt of the completed customer response form which is included with the letter.
Quantity in Commerce12672
DistributionUS nationwide distribution including Puerto Rico. No OUS distribution.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BZD
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