FDAAugust 10, 2023device

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes INS-5905 S...

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

00815686021313008156860213060081568602129000815686021276008156860212690081568602115300815686021108

Recall history

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

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