FDA Device recall Z-0693-2025
Galaxy System (GAL-001)
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Galaxy System (GAL-001) by Noah Medical, citing bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0693-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-25 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Noah Medical |
| Distribution | CA, CT, ID, IL, IN, MA, MD, MO, NC, NJ, NY, OH, PA, TN, VA, WV |
Product
Galaxy System (GAL-001)
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.
Identifiers
| code_info | UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0693-2025%22
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