Z-0693-2025Class II

Galaxy System (GAL-001)

Name: Z-0693-2025 Galaxy System (GAL-001)
Creator: Noah Medical
Published: 2024-10-25
License: https://open.fda.gov/license/

NOAH MEDICAL Corp. / initiated 2024-10-25 / Open, Classified / root cause: design

FDA source

Noah Medical began a recall of Galaxy System (GAL-001) on 2024-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0693-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-25
Posted: 2024-12-18
Recalling firm: NOAH MEDICAL Corp.
Product: Galaxy System (GAL-001)
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/25/24, the firm started hand delivering correction notices to customers informing them of the following: If your device is affected the firm will contact you to inspect and if necessary to replace the power supply. Firm contact: [email protected], 1-888-325-6624
Quantity in commerce: 26
Distribution: US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
Product codes and lots: UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB-1540, CRB-1541, CRB-1543, CRB-1554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0693-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0693-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18

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)