Galaxy System REF GAL-001 (specifically GAL-019, Wired… recallZ-1734-2024 · Noah Medical · initiated Mar 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Noah Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
FDA root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-1734-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 9, 2024
- Posted by the FDA
- May 1, 2024
- Recalling firm
- Noah Medical
- Quantity
- 17 wired controllers
- Product code
- EOQ
- FDA submissions
- K223144
- Distribution
- U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Galaxy System GAL-001Noah Medical Corporation · Bronchoscope (Flexible Or Rigid)5 recalls1 death35 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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