FDA Recall: Medtronic Navigation, Inc.-Boxborough, Interventional Fluoroscopic X-Ray System

infoMedtronicPublished June 21, 2026 at 9:40 PM UTC

Recalling firm: Medtronic Navigation, Inc.-Boxborough

Device class: 2

Device name: Interventional Fluoroscopic X-Ray System

Event initiated: 2026-05-19

FDA posted: 2026-06-15

Recall ID: Z-2451-2026

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

Reason for recall

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

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