Recall archive
54 recalls · page 3 of 3
Reported Mar 12, 2014
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in…
FDA (openFDA device enforcement)
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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