FDA DeviceClass IINotable

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

Date: 2026-06-24
Brand: Medtronic Navigation, Inc.-Boxborough
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

589 units

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