# FDA recall Z-2662-2023

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

## Product

Veran : Endobronchial  Models:  INS-5500	View Optical Probe					  INS-5450	SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx					  INS-5440	View Peripheral Catheter, 3.8mm OD, 2.5mm WC					  INS-5411	0.016" Stylet, 1235 mm L, 10/Bx					  INS-5410	SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx					  INS-5323	Sliding stopper					  INS-5300	"Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm  OD, 5/Bx"

## 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-2662-2023
- **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-2662-2023

## Citation

> AI Analytics. FDA recall Z-2662-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2662-2023. Source: US FDA. Licensed CC0.

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