# FDA recall Z-1734-2024

> **Noah Medical** · Class II · device recall initiated 2024-03-09.

## 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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1734-2024
- **Recalling firm:** Noah Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-09
- **Report date:** 2024-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Carlos, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1734-2024

## Citation

> AI Analytics. FDA recall Z-1734-2024. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1734-2024. Source: US FDA. Licensed CC0.

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