Veran:SPiN Thoracic Navigation System recall
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230…
Why was Veran:SPiN Thoracic Navigation System recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 226 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)