Noah Medical: Medical Device Recall in 2024 - (Recall #: Z-1734-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: March 9, 2024
Date Posted: May 8, 2024
Recall Number: Z-1734-2024
Event ID: 94193
Reason for Recall:

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

Status: Ongoing
Product Quantity: 17 wired controllers
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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated