Noah Medical: Device Recall

Recall Details

Recall Number

Z-0742-2025

Classification

Class II

Product Type

Device

Recalling Firm

Noah Medical

Status

Ongoing

Date Initiated

10/28/2024

Location

San Carlos, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

18

Reason for Recall

Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

Product Description

Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Distribution Pattern

US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC

Other Recalls by Noah Medical

• Class II: Risk 10/25/2024
  Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
• Class II: Risk 10/25/2024
  Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

View all recalls by Noah Medical →