Noah Medical Corporation recalls Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001…

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

On 09/12/2025, the firm sent via FedEx an "Urgent: MEDICAL DEVICE RECALL" Letter to customers. The letter described the product, risk to health and action to be taken. Customers were notified that the password has been removed and they are instructed to: Log in and access the applicable IFU and all addendums. Noah Medical recommends that customers download the IFU and addendums for ease of reference. For questions contact: Noah Medical Customer Service email: customerservice@noahmed.com Noah hotline: 888-325-NOAH (1-888-325-6624)

• FDA enforcement recordOfficial FDA database entry for Z-0598-2026
• FDA 510(k) clearance · K223144The device's official FDA premarket clearance record
• FDA device classification · EOQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Noah Medical CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.