| 2025-09-12 |
Class II
|
Ongoing |
Z-0598-2026 |
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy S… |
— |
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0742-2025 |
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti… |
— |
Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure… |
| 2024-10-25 |
Class II
|
Ongoing |
Z-0693-2025 |
Galaxy System (GAL-001) |
— |
Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, u… |
| 2024-10-25 |
Class II
|
Ongoing |
Z-0679-2025 |
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy S… |
— |
Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in… |
| 2024-03-09 |
Class II
|
Ongoing |
Z-1734-2024 |
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended… |
— |
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. |