Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
This recall is currently active, issued May 1, 2024. It was issued by Noah Medical.
- Company
- Noah Medical
- Recall Initiated
- March 9, 2024
- Posted
- May 1, 2024
- Recall Number
- Z-1734-2024
- Quantity
- 17 wired controllers
- Firm Location
- San Carlos, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Distribution
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Lot / Code Info
Model Number: GAL-001 Wired Controller Model Number: GAL-019 UDI-DI code: 00850048825048 (additional information pending) Serial Numbers: GWC-1529 GWC-1538 GWC-1541 GWC-1576 GWC-1579 GWC-1560 GWC-1566 GWC-1586 GWC-1590 GWC-1581 GWC-1589 GWC-1552 GWC-1572 GWC-1547 GWC-1571 GWC-1564 GWC-1537
Root Cause
Process control
Action Taken
On 03/09-11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx overnight to customers informing them that due to an misalignment calibration of wired controller, it potentially could cause unintended motion of the Galaxy bronchoscope. Customers are instructed to: -Not utilize any of the wired controllers -Remove from service -Return to Noah Medical For any questions, contact Customer Service at 888-325-6624, ext. 3