# FDA recall Z-2660-2023

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

## Product

Veran Endobronchial:  Models:  INS-5925	SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes					  INS-5920	SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes			  INS-5915	SPiN Access Catheter¿ 180 for use w/ Olympus Scopes					  INS-5910	SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes					  INS-5905	SPiN Access Catheter¿ 180 for use w/ Olympus Scopes					  INS-5900	SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes					  INS-5700	SPiN EWC Biopsy Guide Kit

## 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-2660-2023
- **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-2660-2023

## Citation

> AI Analytics. FDA recall Z-2660-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2660-2023. Source: US FDA. Licensed CC0.

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