Reported Jan 1, 2025 · Ongoing

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

Noah Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Noah Medical · 1501 Industrial Rd · San Carlos, CA · 94070-4111

Is this the product you have?

  • Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Lot codes and dates
  • UDI-DI00850048825048
  • Serial Numbers
    • CRB-1502
    • CRB-1503
    • CRB-1506
    • CRB-1508
    • CRB-1516
    • CRB-1517
    • CRB-1519
    • CRB-1520
    • CRB-1521
    • CRB-1522
    • CRB-1523
    • CRB-1524
    • CRB-1525
    • CRB-1527
    • CRB-1528
    • CRB-1529
    • CRB-1530
    • CRB-1532
Amount recalled
18

Where it was sold

Why it was recalled

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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:40 PM UTC

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