# FDA recall Z-2664-2023

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

## Product

Veran : Endobronchial Always on Track  Models:  INS-0392	AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX					  INS-0382	AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx					  INS-0372	AOTT Serrated Forceps, 1.8mm OD, 5/Bx					  INS-0362	AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx					  INS-0352	"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx"					  INS-0322	View Peripheral Catheter, 3.2mm OD, 2.0mm WC					  INS-0305	Always-On Tip Tracked Guidewire, 1.0mm, 950mm					  INS-0304	Always-On Tip Tracked Guidewire, 1.0mm, 735mm					  INS-0050	vPad Patient Tracker, 5/Bx					  INS-0048	vPad Connector Cable

## 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-2664-2023
- **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-2664-2023

## Citation

> AI Analytics. FDA recall Z-2664-2023. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-2664-2023. Source: US FDA. Licensed CC0.

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