# FDA recall Z-2663-2023

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

## Product

Veran : Percutaneous Always on Track  Models:  INS-5040	Always-On vTrack Universal Tracker, LG 7-12ga					  INS-5039	Always-On vTrack Universal Tracker, SM/CL, 12-18ga					  INS-5036	"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point"					  INS-5034	17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point					00815686020354  INS-5032	"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point"				  INS-5029	"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint"					  INS-5028	19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point					  INS-5024	"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point"					  INS-5023	17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point					  INS-5017	17ga x 155mm Tip Tracked Bx Needle					  INS-5016	17ga x 155mm Tip Tracked Bx Needle

## 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-2663-2023
- **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-2663-2023

## Citation

> AI Analytics. FDA recall Z-2663-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2663-2023. Source: US FDA. Licensed CC0.

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