Recall Z-2101-2025— Medtronic Navigation, Inc.-Boxborough

Name: FDA recall Z-2101-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-27

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc.-Boxborough, initiated 2025-05-27. It names one FDA 510(k) clearance: K240465. Product: O-arm O2 Imaging System. Mobile X-Ray System.. Reason: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture..

Recalling firm: Medtronic Navigation, Inc.-Boxborough
Classification: Class II
Status: Ongoing
Initiated: 2025-05-27
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

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

Reason for recall

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

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