FDA Medical Device Recalls (openFDA)
Noah Medical: Galaxy System (GAL-001)
- Recall number
- Z-0693-2025
- Recalling firm
- Noah Medical
- Product
- Galaxy System (GAL-001)
- Status
- Open, Classified
- Initiated
- 2024-10-25
- Posted
- 2024-12-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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
- Quantity
- 26
- Distribution
- US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
- Lot, serial or model codes
- UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB-1540, CRB-1541, CRB-1543, CRB-1554
- 510(k) numbers
- ["K223144"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3021325287
- Firm city
- San Carlos
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28