Recall Z-1849-2012— Medtronic Navigation, Inc.

Name: FDA recall Z-1849-2012
Creator: U.S. Food and Drug Administration
Published: 2010-10-12

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2010-10-12, terminated 2012-06-21. It names one FDA 510(k) clearance: K092564. Product: Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.. Reason: Software Version 3.1.1 does not meet navigational accuracy..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2010-10-12
Terminated: 2012-06-21
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 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.

Reason for recall

Software Version 3.1.1 does not meet navigational accuracy.

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