Z-0742-2025Class II

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

Name: Z-0742-2025 Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for...
Creator: Noah Medical
Published: 2024-10-28
License: https://open.fda.gov/license/

NOAH MEDICAL Corp. / initiated 2024-10-28 / Open, Classified

FDA source

Noah Medical began a recall of Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures on 2024-10-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0742-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-28
Posted: 2024-12-20
Recalling firm: NOAH MEDICAL Corp.
Product: Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
FDA root cause: Component change control
Action: On 10/28/24, recall notices were sent to customers who were told the firm would contact them to arrange inspection and replacement of the power supply system. Share this notification with any other healthcare professionals who may use the system. Complete and return the response form. Firm customer Service: [email protected], 888-325-6624
Quantity in commerce: 18
Distribution: US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
Product codes and lots: UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1506, CRB-1508, CRB-1516, CRB-1517, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1527, CRB-1528, CRB-1529, CRB-1530, CRB-1532,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0742-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0742-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code EOQ

K223144Class IIGalaxy SystemNoah Medical Corp. / cleared 2023-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)