FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1734-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1734-2024
- Event ID
- 94193
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Noah Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2024
- Initiation Date
- March 9, 2024
- Classification Date
- May 1, 2024
- Address
- 1501 Industrial Rd, San Carlos, CA, 94070-4111, United States
Description
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.
Reason
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
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
Distribution
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Quantity
17 wired controllers