Galaxy System (GAL-001)
This recall is currently active, issued December 18, 2024. It was issued by Noah Medical.
- Company
- Noah Medical
- Recall Initiated
- October 25, 2024
- Posted
- December 18, 2024
- Recall Number
- Z-0693-2025
- Quantity
- 26
- Firm Location
- San Carlos, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
Distribution
US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
Lot / Code Info
UDI-DI: 00850048825048. 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, CRB-1540, CRB-1541, CRB-1543, CRB-1554
Root Cause
Device Design
Action Taken
On 10/25/24, the firm started hand delivering correction notices to customers informing them of the following: If your device is affected the firm will contact you to inspect and if necessary to replace the power supply. Firm contact: customerservice@noahmed.com, 1-888-325-6624