Galaxy System (Cart) - Refurbished GALRB-001Recalls & reported problems
Noah Medical Corporation · The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850048825086), received between Aug 7, 2026 and Sep 2, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Gas/Air Leak1
- Use of Device Problem1
Patient problems
- Pneumothorax4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Use of Device Problem
Patient problems: Pneumothorax
MAUDE report 50555629 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50555623 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
Seven days after the biopsy procedure, Noah Medical was made aware that a patient experienced a pneumothorax following a Galaxy-assisted biopsy procedure. The procedure involved biopsy of a right upper lobe (RUL) lesion and was completed successfully. The pneumothorax was identified on a post-procedure X-ray. A chest tube was placed, and the patient was admitted to the hospital. Attempts to gather additional patient demographics were unsuccessful.
Patient problems: Pneumothorax
MAUDE report 50286839 ↗InjuryAug 7, 2026Gas/Air Leak
It was reported that a patient underwent a Galaxy-assisted biopsy of a right lower lobe lesion. During the procedure, anesthesia identified a several-hundred-cubic-centimeter air leak that affected ventilation. The breathing circuit was checked and confirmed closed, and the leak was localized to the interface between the bronchoscope and bronch connector. Saline-soaked gauze partially reduced the leak, and Vaseline gauze subsequently resolved it completely. The patient remained stable, and the procedure was completed without recurrence of the leak. At the end of the procedure, after the bronchoscope was retracted to the endotracheal tube, a right pneumothorax was identified during post-procedure fluoroscopy. A chest tube was placed, and the patient was admitted for management. Attempts to gather additional patient demographics were unsuccessful.
Patient problems: Pneumothorax
MAUDE report 50172456 ↗
Other Bronchoscope (Flexible Or Rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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