Galaxy bronchoscope recall
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Why was Galaxy bronchoscope recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
- Recalling firm
- Noah Medical
- Quantity
- 26
- Distribution
- US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
- Recall date
- December 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)