Noah Medical is recalling 26 Galaxy bronchoscopes (Product GALB-001) used with the Galaxy System (GAL-001). The recall is due to a design issue where certain biopsy tools may not pass through the bronchoscope channel when the device is bent at sharp angles. If a clinician uses excessive force to insert a tool while the scope is in a sharp bend, it could lead to serious medical complications for the patient.
Attempting to force instruments through a significantly bent bronchoscope can lead to airway tissue injury or a collapsed lung (pneumothorax). While no injuries have been reported, the mechanical resistance created by the bend poses a direct risk of internal punctures during medical procedures.
Used with Instructions for use, Part: 10000752. Bronchoscope channel features 2.1mm inner diameter.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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