FDAMay 19, 2026device

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

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

The hazard

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic navigation inc boxboroughmedtronicmedtronic navigation

UPCs

006431696396830064316965181400763000132378007630003555550076300048159900763000496586007630004965930076300049660900763000496630007630004966470076300049666100763000496678

Recall history

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

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Medtronic O-arm O2 Imaging System. Model Number: BI70002000. — Recall Details · AllClear