Recall Z-2451-2026— Medtronic Navigation, Inc.-Boxborough

Name: FDA recall Z-2451-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19. It names one FDA 510(k) clearance: K240465. Product: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.. Reason: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware..

Recalling firm: Medtronic Navigation, Inc.-Boxborough
Classification: Class II
Status: Ongoing
Initiated: 2026-05-19
Firm location: Boxborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K240465 — O-arm O2 Imaging SystemMedtronic Navigation, Inc.·cleared 2024-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.