[pending] Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Descr
Pending LLM rewrite. Source: FDA_DEVICE Z-0598-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
The recalled product
- Product
- Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
- Manufacturer
- Noah Medical Corporation
- Category
- Medical Device — Devices
Distribution
Distributed in 20 states:
- CA
- CO
- ID
- IL
- IN
- MA
- MD
- MN
- MO
- NC
- NJ
- NY
- OH
- PA
- SC
- TN
- VA
- WI
- WV
- WY
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