Noah Medical recalls Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended

Recalled May 8, 2024 · FDA recall Z-1734-2024 · Noah Medical

Hazard

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

Units

17 wired controllers

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Noah Medical

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →