Reported Oct 11, 2023 · Ongoing
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- VeranSPiN
- Thoracic Navigation System ModelsSYS-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
- Lot codes and dates
15 of 15 products
Products covered by this recall # Barcodes Product as published 1 00815686020118SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz 00815686020118 2 00815686020101SYS-4000 SPiN Thoracic Navigation System 00815686020101 3 00815686020095SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 00815686020095 4 00815686020088SYS-3000 SPiN Thoracic Navigation System 00815686020088 5 SYS-2400 SPiN Drive System N/A 6 00815686020071SYS-2230 ig4 System V2, 230V, 50Hz 00815686020071 7 00815686020064SYS-2000 ig4 Image Guides System 00815686020064 8 00815686020057SYS-1500 SPiN View" System 00815686020057 9 SYS-1000 ig4 Image Guides System N/A 10 SYS-0220 ig4 System, 220V, 50Hz N/A 11 00815686020033SYS-0185 SPiN Planning Laptop Workstation 00815686020033 12 SYS-0128 Planning Workstation w/Monitor N/A 13 SYS-0002 ig4 System N/A 14 INS-7150 SPiN Vision Scope Adapter N/A 15 All serial numbers and all lot numbers. - Amount recalled
- 226 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- DE
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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