Noah Medical Corporation is recalling 47 units of the Galaxy System (Model GAL-001) because users are unable to access the Instructions for Use (IFU) and User Manual due to the documents being password protected. The Galaxy System is a bronchoscopic system used by medical professionals to visualize and access patient airways during diagnostic and therapeutic procedures. This software-related issue prevents healthcare providers from accessing essential safety and operating instructions during clinical use.
Without access to the Instructions for Use, medical staff may not be able to operate the device safely or troubleshoot errors, potentially leading to procedural delays or patient harm during lung examinations.
Product Code: EOQ
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.
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Sources: FDA iRES · Raw API Response
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