FDAMay 27, 2025device

O-arm O2 Imaging System. Mobile X-Ray System.

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

The hazard

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic navigation inc boxboroughmedtronicmedtronic navigation

UPCs

00763000709631

Recall history

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

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