# FDA recall Z-2659-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-08-10.

## 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

## Distribution

Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

## Key facts

- **Recall number:** Z-2659-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-10
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2659-2023

## Citation

> AI Analytics. FDA recall Z-2659-2023. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2659-2023. Source: US FDA. Licensed CC0.

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