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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Noah Medical Galaxy Bronchoscopic System Recalled for Potential Power Loss

Agency Publication Date: December 18, 2024
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Summary

Noah Medical has recalled 26 units of its Galaxy Bronchoscopic System (model GAL-001) because a defective component in the power supply may cause the system to lose power suddenly and without warning. This unrecoverable power loss can occur whether the system is plugged into a wall outlet or running on its internal battery. Noah Medical has voluntarily initiated this recall via notification letters to all affected medical facilities to prevent potential procedural failures.

Risk

A power failure during a bronchoscopy procedure could force doctors to manually remove the device from the patient's lungs. This manual removal process increases the risk of serious complications, including lung injury or a collapsed lung (pneumothorax).

What You Should Do

  1. This recall affects Noah Medical Galaxy System (model GAL-001) units with UDI-DI 00850048825048 and specific serial numbers used in medical procedures.
  2. Identify if your device is included by checking the serial number label on the equipment; there are 26 specific serial numbers involved. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to avoid potential power failure during a patient procedure.
  4. Contact Noah Medical or your authorized distributor to arrange for a return, replacement, or correction of the system.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Galaxy System (GAL-001)
Model / REF:
GAL-001
Serial Numbers:
CRB-1502
CRB-1503
CRB-1508
CRB-1513
CRB-1514
CRB-1515
CRB-1516
CRB-1518
CRB-1519
CRB-1520
CRB-1521
CRB-1522
CRB-1523
CRB-1524
CRB-1525
CRB-1528
CRB-1530
CRB-1532
CRB-1534
CRB-1535
CRB-1537
CRB-1538
CRB-1540
CRB-1541
CRB-1543
CRB-1554
UDI:
00850048825048

Quantity: 26 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95712
Status: Active
Manufacturer: Noah Medical
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 26
Distributed To: California, Massachusetts, Pennsylvania, New Jersey, Idaho, Connecticut, Missouri, North Carolina, Maryland, Illinois, Tennessee, Virginia, Ohio, Indiana, West Virginia, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.