Reported Aug 21, 2013 · Terminated
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
- Lot codes and dates
- Lot number(s)Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action
- Amount recalled
- 572
Why it was recalled
Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
This product could cause temporary or reversible health problems — stop using it.
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