Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
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
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Recall record
- Recalling firm
- Olympus Corporation of the Americas
- Product type
- Devices
- Recall number
- Z-2659-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- N/A
- Origin
- Center Valley, PA
- Recall initiated
- 2023-08-10
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2659-2023 · Source: openFDA enforcement.