SPiN Thoracic Navigation System Model: SYS-4000 — Class II medical device recall Z-1103-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-02-15, distributed in FL, GA, IN, MD, MS, NY, OH, PA…. A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7
| Recall number | Z-1103-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2022-12-13 |
| Classified | 2023-02-07 |
| Reported by FDA | 2023-02-15 |
| Distributed | FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 00815686020101 |
| Serial numbers | 85330200430, 87379210921, 87736220412, 87738220412, 87767220420, 87777220415, 87827220427, 87832220502, 87835220505, 87864220509, 87891220517, 87896220519, 87899220524 |
| Model numbers | SYS-4000 |
Product
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Reason for recall
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device
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-1103-2023. 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.