Galaxy System REF GAL-001 — Class II medical device recall Z-1734-2024
Ongoing recall by Noah Medical, reported 2024-05-08, distributed nationwide. Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
| Recall number | Z-1734-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noah Medical, San Carlos, CA, United States |
| Recall initiated | 2024-03-09 |
| Classified | 2024-05-01 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 17 wired |
| UPC / GTIN / UDI-DI | 00850048825048 |
| Serial numbers | GWC-1529, GWC-1537, GWC-1538, GWC-1541, GWC-1547, GWC-1552, GWC-1560, GWC-1564, GWC-1566, GWC-1571, GWC-1572, GWC-1576, GWC-1579, GWC-1581, GWC-1586, GWC-1589, GWC-1590 |
| Model numbers | GAL-001, GAL-019 |
Product
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Reason for recall
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
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-1734-2024. 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.