Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic… — Class II medical device recall Z-2659-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-10-11, distributed nationwide. Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Lap
| Recall number | Z-2659-2023 |
|---|---|
| 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 | 2023-08-10 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 226 units |
| UPC / GTIN / UDI-DI | 00815686020033, 00815686020057, 00815686020064, 00815686020071, 00815686020088, 00815686020095, 00815686020101, 00815686020118 |
| Model numbers | SYS-4230 |
Product
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-2400 SPiN Drive System SYS-2230 ig4 System V2, 230V, 50Hz SYS-2000 ig4 Image Guides System SYS-1500 SPiN View" System SYS-1000 ig4 Image Guides System SYS-0220 ig4 System, 220V, 50Hz SYS-0185 SPiN Planning Laptop Workstation SYS-0128 Planning Workstation w/Monitor SYS-0002 ig4 System INS-7150 SPiN Vision Scope Adapter
Reason for recall
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
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-2659-2023. 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.