Recall archive
53 recalls · page 3 of 3
Reported Aug 21, 2013
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation…
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
FDA (openFDA device enforcement)
Reported Dec 5, 2012
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product details · Reason for recall — Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
FDA (openFDA device enforcement)
Reported Jun 27, 2012
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details · Reason for recall — Software Version 3.1.1 does not meet navigational accuracy.
FDA (openFDA device enforcement)
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