Galaxy System — Class II medical device recall Z-0693-2025
Ongoing recall by Noah Medical, reported 2024-12-25, distributed in CA, CT, ID, IL, IN, MA, MD, MO…. Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/
| Recall number | Z-0693-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noah Medical, San Carlos, CA, United States |
| Recall initiated | 2024-10-25 |
| Classified | 2024-12-18 |
| Reported by FDA | 2024-12-25 |
| Distributed | CA, CT, ID, IL, IN, MA, MD, MO, NC, NJ, NY, OH, PA, TN, VA, WV |
| Quantity | 26 |
| Reason classes | device malfunction |
| UPC / GTIN / 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 and 1 more |
Product
Galaxy System (GAL-001)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0693-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.