Recall Z-0679-2025 ยท EOQ Bronchoscope (Flexible Or Rigid)
Noah Medical
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
| Date | Dec 13, 2024 (initiated Oct 25, 2024) |
| Status | Open, Classified |
| Reason | 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 sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated. |
| Root cause | Device Design |
| Action | On 10/25/24, recall notices were sent to customers who were asked to do the following: A copy of this letter should be kept with the instructions for use which adds additional warnings and precautions to the section Working Channel Tools/Instruments on page 23 of the Instructions for Use. CAUTION: If the bending section of the bronchoscope is articulated sharply and advancement of a biopsy tool encounters increased insertion resistance, straighten the bending section as much as possible to enable resumed advancement of the tool. Use of excessive force during instrument insertion may damage t |
| Quantity | 26 |
| Distribution | US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223144 | Galaxy System Noah Medical Corp., Mar 1, 2023 |