Z-0679-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- October 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
Code Information
UDI-DI: 00850048825048. IFU Revision: J and all prior versions. All bronchoscope lots used with the following system serial numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB1540, CRB-1541, CRB-1543, CRB1554