FDAJuly 25, 2023device

The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of an...

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

The hazard

Ground cable installed incorrectly.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic navigation inc littletonmedtronicmedtronic navigation

UPCs

0076300007412800763000081041007630003555550076300049678400763000542801007630006164340076300061652600763000616564

Recall history

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

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