FDAFDA · Food and drugs·Recall number Z-1734-2024
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.
Published May 8, 2024 · Recall initiated: March 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Noah Medical
- Distributor
- U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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