Z-1734-2024Class II

Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are...

Name: Z-1734-2024 Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are...
Creator: Noah Medical
Published: 2024-03-09
License: https://open.fda.gov/license/

NOAH MEDICAL Corp. / initiated 2024-03-09 / Open, Classified / root cause: manufacturing process

FDA source

Noah Medical began a recall of Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of... on 2024-03-09. FDA classified it as Class II and gives the reason as "Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1734-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-09
Posted: 2024-05-01
Recalling firm: NOAH MEDICAL Corp.
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.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/09-11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx overnight to customers informing them that due to an misalignment calibration of wired controller, it potentially could cause unintended motion of the Galaxy bronchoscope. Customers are instructed to: -Not utilize any of the wired controllers -Remove from service -Return to Noah Medical For any questions, contact Customer Service at 888-325-6624, ext. 3
Quantity in commerce: 17 wired controllers
Distribution: U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Product codes and lots: Model Number: GAL-001 Wired Controller Model Number: GAL-019 UDI-DI code: 00850048825048 (additional information pending) Serial Numbers: GWC-1529 GWC-1538 GWC-1541 GWC-1576 GWC-1579 GWC-1560 GWC-1566 GWC-1586 GWC-1590 GWC-1581 GWC-1589 GWC-1552 GWC-1572 GWC-1547 GWC-1571 GWC-1564 GWC-1537

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1734-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1734-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01

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)