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Open, Classified

Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

FDA Recall Z-0742-2025 · Posted 2024-12-20

Recalling FirmNoah Medical
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2024-10-28
Product Quantity18

Reason for Recall

Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

Firm Action

On 10/28/24, recall notices were sent to customers who were told the firm would contact them to arrange inspection and replacement of the power supply system. Share this notification with any other healthcare professionals who may use the system. Complete and return the response form. Firm customer Service: [email protected], 888-325-6624

Root Cause

Component change control

Distribution Pattern

US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223144Galaxy SystemNoah Medical Corp. · 2023-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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