Noah Medical recalled 47 Galaxy System bronchoscopic visualization devices distributed to 20 US states and internationally to Hong Kong and Australia. The recall centers on password-protected Instructions for Use. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Noah Medical Corporation or your healthcare provider for instructions. Notification method: N/A
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The Galaxy System is a bronchoscopic visualization device used to visualize and access airways for diagnostic and therapeutic procedures.
Access to essential operating instructions is compromised by password protection, creating the potential for improper use during procedures.
This recall is not described as part of a broader industry pattern.
Hospitals and providers may experience procedure delays or need to stop using affected devices until recall instructions are followed.
Recall notice and instructions are on the FDA enforcement page and Noah Medical communications.
Not specified in the provided data.
Retain the recall letter, document device identifiers, and log communications with the manufacturer for records.
Model: GAL-001. Brand: Noah Medical. Description: The Galaxy System bronchoscopic visualization device and accessories. Quantity: 47. Sold/distributed: US states listed; international distribution to Hong Kong and Australia. Recall date: 2025-09-12. Status: Active. Class: II. UDI/Code references include EOQ, CRB-1502, CRB-1530, CRB-1558, CRB-1503, CRB-1531, CRB-1560, CRB-1508, CRB-1534, CRB-1562, CRB-1513, CRB-1535, CRB-1563, CRB-1514, CRB-1537, CRB-1564, CRB-1515, CRB-1539, CRB-1565, CRB-1516, CRB-1540, CRB-1566, CRB-1518, CRB-1541, CRB-1567, CRB-1519, CRB-1542, CRB-1568, CRB-1520, CRB-1545,
No injuries or incidents have been reported.
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