Galaxy System (GAL-001)
FDA device recall Z-0693-2025 · posted 2024-12-18 · Open, Classified
Recall details
- Recalling firm
- Noah Medical
- 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.
- Action taken
- 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: customerservice@noahmed.com, 1-888-325-6624
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 26
- Distribution
- US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
- Date initiated
- 2024-10-25
- Date posted
- 2024-12-18
- Location
- San Carlos, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Galaxy System (K223144) | Noah Medical Corp. | 2023-03-01 |