Galaxy System Wired Controller Recalled for Unintended Scope Motion
Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall without reported injuries or illnesses. The hazard—calibration misalignment causing unintended scope motion during airway procedures—represents a risk-of-harm scenario where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Noah Medical has recalled 17 Galaxy System wired controllers (Model GAL-019). These devices are intended to provide visualization and access to patient airways for diagnostic and therapeutic bronchoscopic procedures.
The recall is due to misaligned calibration of the wired controller that may result in unintended motion of the scope during use. This potential malfunction could compromise the safety and effectiveness of the procedure.
The affected units were distributed nationwide in California, Indiana, Maryland, Missouri, Ohio, and Pennsylvania. The recalled serial numbers are: GWC-1529, GWC-1538, GWC-1541, GWC-1576, GWC-1579, GWC-1560, GWC-1566, GWC-1586, GWC-1590, GWC-1581, GWC-1589, GWC-1552, GWC-1572, GWC-1547, GWC-1571, GWC-1564, and GWC-1537.
The recalled product
- Product
- Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
- Manufacturer
- Noah Medical
- Affected units
- 17
Distribution
Related recalls
Same manufacturer · Noah Medical
See all →- HighGalaxy System bronchoscope power supply defect may injure lung tissue
FDA (Devices) · 2025-01-01
- HighBronchoscopic system may lose power due to defective component
FDA (Devices) · 2024-12-25
- HighGalaxy Bronchoscope Biopsy Tool Insertion Risk at Sharp Bend Angles
FDA (Devices) · 2024-12-18
Same hazard · unintended motion
See all →- High
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- HighNuclear medicine systems may show unintended radial detector motion during scans
FDA (Devices) · 2025-07-16
- HighInfinia nuclear medicine systems may show unintended radial detector motion
FDA (Devices) · 2025-07-16
- HighPhilips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard
FDA (Devices) · 2025-04-30
Similar recalls
- HighGalaxy System bronchoscope power supply defect may injure lung tissue
FDA (Devices) · 2025-01-01
- HighBronchoscopic system may lose power due to defective component
FDA (Devices) · 2024-12-25
- ModerateBronchoscopy robots recalled because the user manual was password protected
FDA (Devices) · 2025-12-03
- HighGalaxy Bronchoscope Biopsy Tool Insertion Risk at Sharp Bend Angles
FDA (Devices) · 2024-12-18
- HighNuclear medicine systems may show unintended radial detector motion during scans
FDA (Devices) · 2025-07-16
- ModerateICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
FDA (Devices) · 2020-05-20