FDAAugust 10, 2023device

Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, C...

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

0081568602070500815686020699008156860203610081568602035400815686020330008156860203090081568602029300815686020255008156860202480081568602022400815686020217

Recall history

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

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