FDAAugust 10, 2023device

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm...

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

008156860206130081568602059000815686020576008156860205380081568602047700815686020446008156860204390081568602040800815686020392

Recall history

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

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