medical Class II Updated 2023-10-11

Olympus Corporation of the Americas recalls Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPi

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model-UDI: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz 00815686020118; SYS-4000 SPiN Thoracic Navigation System 00815686020101; SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 00815686020095; SYS-3000 SPiN Thoracic Navigation System 00815686020088; SYS-2400 SPiN Drive System N/A; SYS-2230 ig4 System V2, 230V, 50Hz 00815686020071; SYS-2000 ig4 Image Guides System 00815686020064; SYS-1500 SPiN View" System 00815686020057; SYS-1000 ig4 Image Guides System N/A; SYS-0220 ig4 System, 220V, 50Hz N/A; SYS-0185 SPiN Planning Laptop Workstation 00815686020033; SYS-0128 Planning Workstation w/Monitor N/A; SYS-0002 ig4 System N/A; INS-7150 SPiN Vision Scope Adapter N/A; All serial numbers and all lot numbers.
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