Recall Z-2244-2012— Medtronic Navigation, Inc.

Name: FDA recall Z-2244-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-11

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2012-07-11, terminated 2016-06-06. It names one FDA 510(k) clearance: K092564. Product: Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.. Reason: A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Terminated: 2016-06-06
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 Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

Reason for recall

A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.

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