Recall Z-0926-2013— Medtronic Navigation, Inc.

Name: FDA recall Z-0926-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-31

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2013-01-31, terminated 2016-07-06. It names one FDA 510(k) clearance: K092564. Product: Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile. Reason: Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction.

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-31
Terminated: 2016-07-06
Firm location: Littleton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K092564 — O-ARM IMAGING SYSTEMMedtronic Navigation, Inc. (Littleton)·cleared 2010-06-17

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 Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

Reason for recall

Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

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