Official recall record

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation

US FDA — Medical Devices · 2023-08-10 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-08-10
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00815686020118
Brand on record: Olympus Corporation of the Americas

What the authority reported

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 to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Other recalls from this brand

All 21 official recall notices naming Olympus Corporation of the Americas on this site →

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