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-1502CRB-1503CRB-1506CRB-1508CRB-1516CRB-1517CRB-1519CRB-1520CRB-1521CRB-1522CRB-1523CRB-1524CRB-1525CRB-1527CRB-1528CRB-1529CRB-1530CRB-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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.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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