Olympus Corporation of the Americas: Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 23

Hazard

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

Details from the source

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. Quantity: 226 units 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.

UPC codes

00815686020118, 00815686020101, 00815686020095, 00815686020088, 00815686020071, 00815686020064, 00815686020057, 00815686020033

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.