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

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

Tags

FDA recall, medical device, class 2, Radiology, Under Investigation by firm, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering

Source record id

Z-2451-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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