Recall Z-2082-2016— Medtronic Navigation, Inc.-Littleton

Name: FDA recall Z-2082-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-17

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc.-Littleton, initiated 2016-03-17, terminated 2021-04-06. It names one FDA 510(k) clearance: K092564. Product: Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028. Reason: It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure..

Recalling firm: Medtronic Navigation, Inc.-Littleton
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Terminated: 2021-04-06
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 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Reason for recall

It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

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