FDAAugust 10, 2023device

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 Syste...

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0081568602011800815686020101008156860200950081568602008800815686020071008156860200640081568602005700815686020033

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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