Home / Recalls / Noah Medical / Z-1734-2024

Z-1734-2024 Class II Ongoing

Recalled by Noah Medical — San Carlos, CA

Recall Details

Product Type: Devices
Report Date: May 8, 2024
Initiation Date: March 9, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17 wired controllers

Product 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 for Recall

Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

Distribution Pattern

U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.

Code Information

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