Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy Syst
FDA device recall Z-0598-2026 · posted 2025-11-26 · Open, Classified
Recall details
- Recalling firm
- Noah Medical Corporation
- Reason for recall
- Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
- Action taken
- 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)
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 47
- Distribution
- US distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN, PA, MD, VA, WI, CO, SC, IL, NC and OUS (Foreign) to countries of: Hong Kong and Australia
- Date initiated
- 2025-09-12
- Date posted
- 2025-11-26
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Galaxy System (K223144) | Noah Medical Corp. | 2023-03-01 |